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Trial record 2 of 6 for:    ivermectin united state | covid-19

An Outpatient Clinical Trial Using Ivermectin and Doxycycline in COVID-19 Positive Patients at High Risk to Prevent COVID-19 Related Hospitalization

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04729140
Recruitment Status : Recruiting
First Posted : January 28, 2021
Last Update Posted : April 1, 2021
Sponsor:
Information provided by (Responsible Party):
Max Health, Subsero Health

Brief Summary:
The purpose of this Clinical trial is to explore the therapeutic benefits of Ivermectin and Doxycycline in different combinations in high risk patients diagnosed with COVID-19.

Condition or disease Intervention/treatment Phase
Covid19 Drug: Ivermectin Tablets Drug: Doxycycline Tablets Drug: Placebo Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blinded, prospective, placebo controlled outpatient randomized clinical trial.
Masking: Triple (Participant, Care Provider, Investigator)
Masking Description: Data analysis will be carried out using statistical package for the social sciences software (SPSS). Interim data analysis will be performed at three different levels of the number of participants starting at sample size 20, 30 and 50. If no significant findings are obtained from the data at N=50, then it will add more participants to the study to achieve statistical significance. Sponsor and Principal Investigator will defer data analysis to a statistician. A Data Monitoring Committee (DMC) is going to be established in order to review accumulating trial data by treatment group in order to monitor patient safety and efficacy, ensure validity and integrity of the trial and make benefit-risk assessment. This is going to be conducted by a third party external DMC.
Primary Purpose: Treatment
Official Title: A Randomized Double-blinded Placebo-controlled Outpatient Clinical Trial in High Risk Population Confirmed COVID-19 Patients Using Ivermectin and Doxycycline to Prevent COVID-19 Illness-related Hospitalization (COVIVER-OUT PLUS)
Actual Study Start Date : December 28, 2020
Estimated Primary Completion Date : December 28, 2021
Estimated Study Completion Date : March 28, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ivermectin plus Doxycycline

Ivermectin 200 mcg/kg on day 1 and day 2-plus doxycycline 100 mg tablets twice a day for seven days

Body Weight (kg) Single oral Dose number of 3 mg tablets of Ivermectin

15-24 kg 1 tablet

25-35 kg 2 tablets

36-50 kg 3 tablets

51-65 kg 4 tablets

66-79 kg 5 tablets

80-109 kg 6 tablets

>110 kg 7 tablets

Drug: Ivermectin Tablets
Double-blinded, prospective, placebo controlled outpatient randomized clinical trial.

Drug: Doxycycline Tablets
Double-blinded, prospective, placebo controlled outpatient randomized clinical trial.

Active Comparator: Ivermectin plus Placebo

Ivermectin 200 mcg/kg on day 1 and day 2-plus placebo tablet twice a day for seven days

Body Weight (kg) Single oral Dose number of 3 mg tablets of Ivermectin and Placebo

15-24 kg 1 tablet

25-35 kg 2 tablets

36-50 kg 3 tablets

51-65 kg 4 tablets

66-79 kg 5 tablets

80-109 kg 6 tablets

>110 kg 7 tablets

Drug: Ivermectin Tablets
Double-blinded, prospective, placebo controlled outpatient randomized clinical trial.

Drug: Placebo
Double-blinded, prospective, placebo controlled outpatient randomized clinical trial.

Placebo Comparator: Placebo plus Placebo

Placebo (number of tablets according to weight) plus placebo twice a day for seven days

Body Weight (kg) Single oral Dose number of 3 mg tablets of Placebo

15-24 kg 1 tablet

25-35 kg 2 tablets

36-50 kg 3 tablets

51-65 kg 4 tablets

66-79 kg 5 tablets

80-109 kg 6 tablets

>110 kg 7 tablets

Drug: Placebo
Double-blinded, prospective, placebo controlled outpatient randomized clinical trial.




Primary Outcome Measures :
  1. Decreased admission rate to the hospital secondary to respiratory illness related to COVID-19 [ Time Frame: 5 weeks ]
    The investigators will be assessing for decreased admission rate to the hospital secondary to respiratory illness related to COVID-19. This will be assessed over the duration of 5 weeks.


Secondary Outcome Measures :
  1. Decrease in total duration of symptoms secondary to respiratory illness related to COVID-19 [ Time Frame: 5 weeks ]
    The investigators will be assessing for a decrease in total duration of symptoms secondary to respiratory illness related to COVID-19. This will be assessed over the duration of 5 weeks.

  2. Assessment of White Blood Cell Count [ Time Frame: 2 weeks ]
    The investigators will assess the patient's White Blood Cell Count (WBC) at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients White Blood Cell count in cells/Liter. The investigators will monitor for increases or decreases in the WBC count value throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  3. Assessment of Hemoglobin level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Hemoglobin (Hgb) level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Hemoglobin count in grams/deciliter (g/dl). The investigators will monitor for increases or decreases in the Hgb value throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  4. Assessment of Hematocrit level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Hematocrit (Hct) level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Hematocrit in units of percentage (%). The investigators will monitor for increases or decreases in the Hct value throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  5. Assessment of Platelet Count [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Platelet Count level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Platelet Count in units of platelets per microliter. The investigators will monitor for increases or decreases in the Platelet count throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  6. Assessment of Sodium level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Sodium (Na) at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Sodium level in units of milliequivalents per liter (mEq/L). The investigators will monitor for increases or decreases in the Sodium level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  7. Assessment of Potassium level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Potassium (K) at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Potassium level in units of milliequivalents per liter (mEq/L). The investigators will monitor for increases or decreases in the Potassium level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  8. Assessment of Chloride level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Chloride (Cl) at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Chloride level in units of millimoles per liter (mmol/L). The investigators will monitor for increases or decreases in the Chloride level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  9. Assessment of Carbon Dioxide level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Carbon Dioxide (C02) level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Carbon Dioxide level in units of millimoles per liter (mmol/L). The investigators will monitor for increases or decreases in the Carbon Dioxide level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  10. Assessment of Blood Urea Nitrogen level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Blood Urea Nitrogen (BUN) level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Blood Urea Nitrogen level in units of milligrams per deciliter (mg/dL). The investigators will monitor for increases or decreases in the Blood Urea Nitrogen level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  11. Assessment of Creatinine level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Creatinine (Crt) level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Creatinine level in units of milligrams per deciliter (mg/dL). The investigators will monitor for increases or decreases in the Creatinine level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  12. Assessment of Calcium level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Calcium (Ca) level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Calcium level in units of milligrams per deciliter (mg/dL). The investigators will monitor for increases or decreases in the Calcium level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  13. Assessment of Glucose level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Glucose level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Glucose level in units of milligrams per deciliter (mg/dL). The investigators will monitor for increases or decreases in the Glucose level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  14. Assessment of Total Bilirubin level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Total Bilirubin (T bili) level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Total Bilirubin level in units of milligrams per deciliter (mg/dL). The investigators will monitor for increases or decreases in the Total Bilirubin level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  15. Assessment of Total Protein level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Total Protein level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Total Protein level in units of grams per deciliter (g/dL). The investigators will monitor for increases or decreases in the Total Protein level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  16. Assessment of Albumin level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Albumin level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Albumin level in units of grams per deciliter (g/dL). The investigators will monitor for increases or decreases in the Albumin level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  17. Assessment of Aspartate Aminotransferase level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Aspartate Aminotransferase (AST) level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Aspartate Aminotransferase level in units of International Units per liter (IU/L). The investigators will monitor for increases or decreases in the Aspartate Aminotransferase level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  18. Assessment of Alanine Aminotransferase level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Alanine Aminotransferase (ALT) level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Alanine Aminotransferase level in units of International Units per liter (IU/L). The investigators will monitor for increases or decreases in the Alanine Aminotransferase level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  19. Assessment of Alkaline Phosphatase level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Alkaline Phosphatase (ALP) level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Alkaline Phosphatase level in units of International Units per liter (IU/L). The investigators will monitor for increases or decreases in the Alkaline Phosphatase level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  20. Assessment of Ferritin [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Ferritin level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Ferritin level measured in micrograms per liter (mg/L). The investigators will monitor for increases or decreases in the Ferritin level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  21. Assessment of D-dimer [ Time Frame: 2 weeks ]
    The investigators will assess the patient's D-dimer level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients D-dimer level measured in micrograms per milliliter fibrinogen equivalent units (mcg/mL FEU). The investigators will monitor for increases or decreases in the D-dimer level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  22. Assessment of Creatine Phosphokinase [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Creatine Phosphokinase level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Creatine Phosphokinase level measured in units per liter (U/L). The investigators will monitor for increases or decreases in the Creatine Phosphokinase level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  23. Assessment of C-Reactive Protein [ Time Frame: 2 weeks ]
    The investigators will assess the patient's C-Reactive Protein level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients C-Reactive Protein level measured in milligrams per liter (mg/L). The investigators will monitor for increases or decreases in the C-Reactive Protein level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  24. Assessment of Prothrombin Time and International Normalized Ratio [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Prothrombin Time and International Normalized Ratio (INR) at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Prothrombin Time measured in seconds and International Normalized Ratio measured in it's own units. The investigators will monitor for increases or decreases in the Prothrombin Time and International Normalized Ratio throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  25. Assessment of activated Partial Thromboplastin Time [ Time Frame: 2 weeks ]
    The investigators will assess the patient's activated Partial Thromboplastin Time at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients activated Partial Thromboplastin Time in seconds. The investigators will monitor for increases or decreases in the activated Partial Thromboplastin Time throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  26. Assessment of Fibrinogen Activity [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Fibrinogen Activity at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Fibrinogen Activity in milligrams per deciliter (mg/dl). The investigators will monitor for increases or decreases in Fibrinogen Activity throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  27. Assessment of Interleukin 6 level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Interleukin 6 level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Interleukin 6 level in units of picograms per milliliter (pg/mL). The investigators will monitor for increases or decreases in the Total Interleukin 6 level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  28. Assessment of Interleukin 6 receptor level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Interleukin 6 receptor level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Interleukin 6 receptor level in units of picograms per milliliter (pg/mL). The investigators will monitor for increases or decreases in the Total Interleukin 6 level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  29. Assessment of Tumor Necrosis Factor Alpha level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Tumor Necrosis Factor Alpha level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Tumor Necrosis Factor Alpha level in units of picograms per milliliter (pg/mL). The investigators will monitor for increases or decreases in the Tumor Necrosis Factor Alpha level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  30. Assessment of Tumor Necrosis Factor Alpha Receptor level [ Time Frame: 2 weeks ]
    The investigators will assess the patient's Tumor Necrosis Factor Alpha Receptor level at the onset of trial enrollment and at day 7 and day 14. The investigator's will monitor the patients Tumor Necrosis Factor Alpha Receptor level in units of picograms per milliliter (pg/mL). The investigators will monitor for increases or decreases in the Tumor Necrosis Factor Alpha Receptor level throughout the first 2 weeks of trial enrollment. Participants will have their blood work sent to a designated laboratory.

  31. Mortality [ Time Frame: 5 weeks ]
    The investigators will assess for any reductions or increase in mortality during the duration of the study.

  32. Measurement of Participants with Medication Side Effects [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of medication side effects on a twice a week basis for the duration of 5 weeks using a standardized form. The investigators will ask about rash/itching/hives, bleeding/easy bruising of skin, palpitations or irregular heart beats, vision disturbances or blurry vision, light flashes or light streak in vision, fainting spells, seizure, headaches, nausea or vomiting, ringing in the ears, loss of appetite, loss of taste sensation, oral ulcers, abdominal pain, diarrhea or loss stools, yellow discoloration of eyes or skin, upper extremity or lower extremity muscle weakness, mood changes, teeth discoloration, photosensitivity or sunburn reactions after sun exposure, or any other effects. This may occur via Tele-Health visits or via in person visits.

  33. Measurement of Participants with new onset Shortness of Breath or Changes in Shortness of Breath Severity [ Time Frame: 5 weeks ]
    The investigators will assess for new onset Shortness of Breath or changes in the severity of Shortness of Breath on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if Shortness of Breath is present and grade the severity of Shortness of Breath if present (mild, moderate, severe). Moderate to Severe Shortness of Breath will be immediately reported to the Principal Investigator. This may occur via Tele-Health visits or via in person visits.

  34. Measurement of Participants Pulse Oximetry readings on room air [ Time Frame: 5 weeks ]
    The investigators will assess Pulse Oximetry readings on room air on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record Pulse Oximetry readings on room air. If the Pulse Oximetry readings on room air are less then 93% on room air or drop by 4% from baseline established at the onset of the study, the Prinicipal Investigator will be notified. This may occur via Tele-Health visits or via in person visits.

  35. Measurement of Participants with new onset Red Eyes or Changes in Red Eyes Severity [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of Red Eyes or changes in the severity of Red Eyes on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if Red Eyes are present and grade the severity of Red Eyes if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  36. Measurement of Participants with new onset Chills or Changes in Chills Severity [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of Chills or changes in the severity of Chills on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if Chills are present and grade the severity of Chills if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  37. Measurement of Participants with new onset Runny Nose or Changes in Runny Nose Severity [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of Runny Nose or changes in the severity of Runny Nose on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if Runny Nose is present and grade the severity of Runny Nose if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  38. Measurement of Participants with new onset Sore Throat or Changes in Sore Throat Severity [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of Sore Throat or changes in the severity of Sore Throat on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if Sore Throat is present and grade the severity of Sore Throat if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  39. Measurement of Participants with new onset Loss of Smell or Changes in Severity of in Loss of Smell [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of Loss of Smell or changes in the severity of Loss of Smell on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if Loss of Smell is present and grade the severity of Loss of Smell if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  40. Measurement of Participants with new onset Loss of Taste or Changes in Severity of Loss of Taste [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of Loss of Taste or changes in the severity of Loss of Taste on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if Loss of Taste is present and grade the severity of Loss of Taste if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  41. Measurement of Participants with new onset Body Aches or Body Pains or Changes in Body Aches or Body Pains Severity [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of Body Aches or Body Pains or changes in the severity of Body Aches or Body Pains on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if Body Aches or Body Pains are present and grade the severity of Body Aches or Body Pains if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  42. Measurement of Participants with new onset Diarrhea or Changes in Diarrhea Severity [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of Diarrhea or changes in the severity of Diarrhea on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if Diarrhea is present and grade the severity of Diarrhea if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  43. Measurement of Participants with new onset Headaches or Changes in Headaches Severity [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of Headaches or changes in the severity of Headaches on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if Headaches are present and grade the severity of Headaches if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  44. Measurement of Participants with new onset Anxiety or Changes in Anxiety Severity [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of Anxiety or changes in the severity of Anxiety on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if Anxiety is present and grade the severity of Anxiety if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  45. Measurement of Participants with new onset Fatigue or Changes in Fatigue Severity [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of fatigue or changes in the severity of fatigue on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if fatigue is present and grade the severity of fatigue if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  46. Measurement of Participants with new onset Trouble Concentrating or Changes in Trouble Concentrating Severity [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of Trouble Concentrating or changes in the severity of Trouble Concentrating on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if Trouble Concentrating is present and grade the severity of Trouble Concentrating if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  47. Measurement of Participants with new onset Cough or Changes in Cough Severity [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of cough or changes in the severity of cough on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if cough is present and grade the severity of cough if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  48. Measurement of Participants with new onset Vomiting or Changes in Vomiting Severity [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of vomiting or changes in the severity of vomiting on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if vomiting is present and grade the severity of vomiting if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  49. Measurement of Participants with new onset Nausea or Changes in Nausea Severity [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of nausea or changes in the severity of nausea on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if nausea is present and grade the severity of nausea if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  50. Measurement of Participants with new onset Feelings of Hopelessness or Changes in Feelings of Hopelessness severity [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of feelings of hopelessness or changes in the severity of feelings of hopelessness on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if feelings of hopelessness are present and grade the severity of hopelessness if present (mild, moderate, severe). If more then mild, the investigators will utilize the Hamilton Depression Scale. This may occur via Tele-Health visits or via in person visits.

  51. Measurement of Participants with new onset feelings of Depression or Changes in feelings of Depression severity [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of feelings of depression or changes in the severity of feelings of depression on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if feelings of depression are present and grade the severity of feelings of depression if present (mild, moderate, severe). If more then mild, the investigators will utilize the Hamilton Depression Scale. This may occur via Tele-Health visits or via in person visits.

  52. Measurement of Participants with new onset Fever or Changes in Fever Severity [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of a fever or changes in the severity of fever on a twice a week basis for the duration of 5 weeks. The investigators will be monitoring for fever in Fahrenheit (F). The investigators will be using a standardized form which will record if fever is present and grade the severity of fever if present (mild fever at 100.4 degrees F to 101 degrees F, moderate fever at 101.1 to 101.9 degrees, severe fever at greater then 102 degrees). We will also record the temperatures in the standardized form. This may occur via Tele-Health visits or via in person visits.

  53. Measurement of Participants with new onset Moving Slowly or Changes in the Severity of Moving Slowly [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of moving slowly or changes in severity of moving slowly on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if moving slowly is present and grade the severity of moving slowly if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  54. Measurement of Participants with new onset Speaking Slowly or Changes in the Severity of Speaking Slowly [ Time Frame: 5 weeks ]
    The investigators will assess for new onset of speaking slowly or changes in severity of speaking slowly on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if speaking slowly is present and grade the severity of speaking slowly if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  55. Measurement of Participants with new onset Feelings of Restlessness or Changes in the Severity of Feelings of Restlessness [ Time Frame: 5 weeks ]
    The investigators will assess for new onset feelings of restlessness or changes in severity of feelings of restlessness on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if feelings of restlessness are present and grade the severity of these feelings of restlessness if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  56. Measurement of Participants with new onset Thoughts of Better Off Being Dead or Changes in the Severity of Thoughts of Better Off Being Dead [ Time Frame: 5 weeks ]
    The investigators will assess for new onset thoughts of better off being dead or changes in severity of thoughts of better off being dead on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if thoughts of better off being dead are present and grade the severity of these thoughts of better off being dead if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  57. Measurement of Participants with new onset Thoughts of Hurting Yourself or Changes in the Severity of Thoughts of Hurting Yourself [ Time Frame: 5 weeks ]
    The investigators will assess for new onset thoughts of hurting yourself or changes in severity of thoughts of hurting yourself on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if thoughts of hurting yourself are present and grade the severity of these thoughts of hurting yourself if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  58. Measurement of Participants with new onset Loss of Interest in Doing Things or Changes in the Severity of Loss of Interest in Doing Things [ Time Frame: 5 weeks ]
    The investigators will assess for new onset loss of interest in doing things or changes in the severity of loss of interest in doing things on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if loss of interest in doing things are present and grade the severity of the loss of interest in doing things if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  59. Measurement of Participants with new onset Loss of Pleasure in Doing Things or Changes in the Severity of Loss of Pleasure in Doing Things [ Time Frame: 5 weeks ]
    The investigators will assess for new onset loss of pleasure in doing things or changes in the severity of loss of pleasure in doing things on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if loss of pleasure in doing things are present and grade the severity of the loss of pleasure in doing things if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  60. Measurement of Participants with new onset Trouble Falling Asleep or Changes in the Severity of Trouble Falling Asleep [ Time Frame: 5 weeks ]
    The investigators will assess for new onset trouble falling asleep or changes in the severity of trouble falling asleep on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if trouble falling asleep are present and grade the severity of the trouble falling asleep if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  61. Measurement of Participants with new onset Trouble Staying Asleep or Changes in the Severity of Trouble Staying Asleep [ Time Frame: 5 weeks ]
    The investigators will assess for new onset trouble staying asleep or changes in the severity of trouble staying asleep on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if trouble staying asleep is present and grade the severity of trouble staying asleep if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.

  62. Measurement of Participants with new onset Unmentioned Negative Impacts of COVID 19 infection or Changes in the Severity of these Negative Impacts of COVID 19 infection [ Time Frame: 5 weeks ]
    The investigators will assess for new onset unmentioned negative impacts of COVID 19 infection or changes in the severity of these unmentioned negative impacts of COVID 19 infection on a twice a week basis for the duration of 5 weeks. The investigators will be using a standardized form which will record if unmentioned negative impacts of COVID 19 infection are present and grade the severity of these unmentioned negative impacts of COVID 19 infection if present (mild, moderate, severe). This may occur via Tele-Health visits or via in person visits.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age greater than or equal to 18
  • Willing and able to provide verbal /telephonic/Personal or computer based Informed Consent
  • Experiencing symptoms of COVID-19 illness and tested positive for SARS CoV-2 with either PCR, NAAT or antigen testing
  • Residents in a Nursing Home or long-term care facility
  • Immunocompromised state, including solid organ transplant, HIV infection, other immune deficiency, immunosuppressant medication including systemic corticosteroids
  • Chronic lung disease, including Chronic Obstructive Pulmonary Disease (COPD), moderate to severe asthma, cystic fibrosis, pulmonary fibrosis
  • Cardiovascular Disease
  • Cancer
  • Hypertension
  • Obesity (body mass index [BMI greater then or equal to 30 kg/m^2]
  • Diabetes Mellitus
  • Chronic Kidney Disease
  • Chronic Liver Disease
  • Cerebrovascular Disease
  • Neurological Disorders including dementia
  • Tobacco use disorders
  • Hematologic disorders, including sickle cell disease and thalassemia

We are also interested in including a vital population to protect, considered essential workers who may not fit into the above inclusion criteria:

  • Health care professionals and firefighters.
  • Government officials or employees.
  • Students and teachers.
  • Law enforcement agents and personnel.
  • Individuals who live with, and cannot isolate, from any of the above groups.

Exclusion Criteria:

  • Participants under the age of 18
  • Received any COVID vaccine within the last 30 days
  • Contraindications to Ivermectin or Doxycycline
  • History of Seizure Disorder or Epilepsy
  • History of Myocardial Infarction or Heart Attack within the last one month
  • Already receiving Ivermectin or Doxycycline for treatment of any other disease or disorder
  • Allergies to Ivermectin or Doxycycline including angioedema, severe asthma, exfoliative dermatitis, Steven Jonson syndrome or psoriasis
  • History of angioedema, exfoliative dermatitis, Steven Johnson syndrome, psoriasis
  • Currently Pregnant or planning to conceive soon
  • Breastfeeding
  • History of prior Clostridium Difficile infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04729140


Contacts
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Contact: Inita Bedi 941 371 3500 ibedi@mymaxdoc.com
Contact: Werther Marciales, MD 941 545 8857 werther40@msn.com

Locations
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United States, Florida
MAX HEALTH, Subsero Health 2055 Wood Street, Suite 100 Recruiting
Sarasota, Florida, United States, 34237
Contact: Inita Bedi    941-371-3500    ibedi@mymaxdoc.com   
Contact: Werther Marciales, MD    941 545 8857    werther40@msn.com   
Sponsors and Collaborators
Max Health, Subsero Health
Investigators
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Principal Investigator: Werther Marciales, MD Clinical Trial Principal Investigator
Principal Investigator: Ryan Salom sub Clinical Trial Prinicipal Investigator
Principal Investigator: Faheem Ahmad, MD sub Clinical Trial Prinicipal Investigator
Principal Investigator: Divisha Sharma, MD Clinical Trial Investigator
Principal Investigator: Nicholas Guy Ross, DO Clinical Trial Investigator
Principal Investigator: Terry Fredeking Clinical Trial Investogator
Principal Investigator: Michael Ricciardi, PhD Clinical Trial Investogator
Publications:
[1] World Health Organization. Novel Coronavirus-China [cited 2020 January 12]. https://www.who.int/csr/don/12-january-2020-novel-coronavirus-chinaExternal Link
[2] Interim U.S. Guidance for Risk Assessment and Public Health Management of Persons with Potential Coronavirus Disease 2019 (COVID-19) Exposures: Geographic Risk and Contacts of Laboratory-confirmed Cases. www.cdc.gov/coronavirus/2019-ncov/php/risk-assessment.
[5] The RECOVERY trial in COVID-19 has provided initial results of the dexamethasone arm https://www.recoverytrial.net/files/recovery_dexamethasone_statement_160620_final.pdf
[6] U.S. Food and Drug Administration. FDA cautions against the use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to the risk of heart rhythm problems. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-cautions-against-use-hydroxychloroquine-or-chloroquine-covid-19-outside-hospital-setting-or (Accessed on April 24, 2020).
[7] Georgi Momekov & Denitsa Momekova (2020) Ivermectin as a potential COVID-19 treatment from the pharmacokinetic point of view: antiviral levels are not likely attainable with known dosing regimens, Biotechnology & Biotechnological Equipment, 34:1, 469-474, DOI: 10.1080/13102818.2020.1775118
[8] ICON (Ivermectin in COvid Nineteen) study: Use of Ivermectin is Associated with Lower Mortality in Hospitalized Patients with COVID19 Juliana CepelowiczRajter, M.D. 1 Michael S. Sherman, M.D.2NaazFatteh, M.D. 1 Fabio Vogel, Pharm. D., BCPS1 Jamie Sacks, Pharm. D. 1 Jean-Jacques Rajter, M.D.1,3 1. Broward Health Medical Center, Fort Lauderdale, FL 2. Emeritus Professor, Drexel University College of Medicine 3. Assistant Professor, Florida International University Corresponding author: Jean-Jacques Rajter, MD covid19@pscflorida.com
[9] The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro, Leon Calya, Julian D. Drucea, Mike G. Cattona, David A. Jans, Kylie M. Wagstaffb,∗ a Victorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital, At the Peter Doherty Institute for Infection and Immunity, Victoria, 3000, Australia b Biomedicine Discovery Institute, Monash University, Clayton, Vic, 3800,
[10] Ivermectin: a potential candidate for the treatment of COVID 19 Dhyuti Gupta 1, Ajaya Kumar Sahoo 1, Alok Singh ∗,1 Department of Pharmacology, All India Institute of Medical Sciences, Raipur, Chhattisgarh, India
[11] Loukas A, Hotez PJ. Chemotherapy of helminth infections. In: Brunton LL, Lazo JS, Parker KL, editors. Goodman & Gilman's The pharmacological basis of therapeutics. 11th ed. New York (N.Y.): McGraw Hill; 2006. p. 1073-1093.
[14] Dalvi P.S.; Singh A; Trivedi HR; et al. (2011).
[16] Goodman and Gilman's The Pharmacological Basis of Therapeutics, 11th edition, page 122, 1084-1087.
[17] COMFORTIS® and ivermectin interaction Safety Warning Notification
[19] Information for Clinicians on Therapeutic Options for COVID-19 Patients. www.cdc.gov/coronavirus/2019-ncov/hcp/therapeutic-options.
[21] Sodhi M, Etminan M. Therapeutic Potential for Tetracyclines in the Treatment of COVID-19 [published online ahead of print, 2020 April 8]. Pharmacotherapy. 2020;10.1002/phar.2395. doi:10.1002/phar.2395.

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Responsible Party: Max Health, Subsero Health
ClinicalTrials.gov Identifier: NCT04729140    
Other Study ID Numbers: COVIVER-OUT PLUS
First Posted: January 28, 2021    Key Record Dates
Last Update Posted: April 1, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: We will release data once the clinical trial has completed course. An independent data safety committee will analyze interim data for effectiveness and safety.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: December 28 2020 to March 28 2022

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Max Health, Subsero Health:
COVID 19
Ivermectin
Doxycycline
Additional relevant MeSH terms:
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Doxycycline
Ivermectin
Anti-Bacterial Agents
Anti-Infective Agents
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents