Clinical Impact of BACTEK-R in Subject With Mild Pneumonia Due to COVID-19 Infection
|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: NCT04363814|
Recruitment Status : Recruiting
First Posted : April 27, 2020
Last Update Posted : June 30, 2020
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Biological: Bactek-R||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Open-label, Randomized Pilot Study (Including a Control Group) of BACTEK-R (MV130), Administered Sublingually to Assess the Clinical Impact in Subjects With Mild Pneumonia Due to COVID-19|
|Actual Study Start Date :||June 10, 2020|
|Estimated Primary Completion Date :||July 1, 2021|
|Estimated Study Completion Date :||July 31, 2021|
Subject included in the experimental group will receive Bactek- R.The dose consists on 3 spray puff every 6 hours for 2 weeks.
BACTEK-R is a bacterial preparation that contains a mixture of Gram + and Gram - inactivated bacteria at the concentration of 300 FTU / mL (approx. 10^9 bacteria / mL)
No Intervention: Control
Subject included in the control group will receive standard therapy for COVID-19.
- Clinical recovery [ Time Frame: 2 weeks ]Number of subjects presenting a improvement in their clinical condition from day 1 to 14 that lead their hospital discharged. Based on the measure of the secondary outcomes.
- Clinical worsening [ Time Frame: 2 weeks ]Number of subjects presenting a worsening in their clinical condition from day 1 to 14 that leads to their admission to the intensive care unit or their death. Based on the measure of the secondary outcomes.
- Clinical severity [ Time Frame: 2 weeks ]Symptom (fever, cough, dyspnea, myalgia, diarrhea and so on) will be daily record and classified as mild, moderate, severe.
- Time to symptoms remission [ Time Frame: 2 weeks ]Time of reduction or disappearance of the symptoms
- Medication Use [ Time Frame: 2 weeks ]Record of all the medication administered to the subject
- Hospitalization time [ Time Frame: 2 weeks ]Time from the subject's admission to the coronavirus unit until discharge
- Blood routine test [ Time Frame: Days 1 and 7 ]Blood routine test will be carried out days 1 and 7
- Heart rate [ Time Frame: 2 weeks ]Heart rate will be followed everyday during time frame
- Blood pressure [ Time Frame: 2 weeks ]Blood pressure will be followed everyday during time frame
- Cardiac auscultation [ Time Frame: 2 weeks ]Cardiac auscultation will be recorded everyday during time frame
- Oxygen saturation [ Time Frame: 2 weeks ]Blood oxygen saturation will be followed everyday during time frame
- Adverse events [ Time Frame: 2 weeks ]Adverse events during treatment
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): NCT04363814
|Contact: Guillermo Ángeles, MD||809 399 email@example.com|
|Contact: Miguel Casanovas, PhD; MDfirstname.lastname@example.org|
|Hospital Metropolitano Santiago||Recruiting|
|Santiago De Los Caballeros, Dominican Republic, 51000|
|Contact: Nicolas Batlle, MD +1 829-947-2222|
|Principal Investigator:||Martín Medrano, MD|
|Principal Investigator:||Nicolas Batlle, MD|
|Principal Investigator:||Raymundo Hernández|
|Principal Investigator:||Natalia García|
|Principal Investigator:||M. Polanco|
|Study Director:||Guillermo Ángeles|