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Trial of Combination Therapy to Treat 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: NCT04482686
Recruitment Status : Not yet recruiting
First Posted : July 22, 2020
Last Update Posted : September 21, 2020
Sponsor:
Collaborator:
Topelia Therapeutics
Information provided by (Responsible Party):
ProgenaBiome

Brief Summary:
In this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.

Condition or disease Intervention/treatment Phase
COVID Covid-19 Corona Virus Infection Coronavirus Infection Coronavirus-19 SARS-CoV2 SARS-CoV Infection Drug: Ivermectin Drug: Doxycycline Hcl Dietary Supplement: Zinc Dietary Supplement: Vitamin D3 Dietary Supplement: Vitamin C Phase 2

Detailed Description:
Patients in this trial will undergo treatment for 10 days with either a combination of therapies or placebo. They will then be followed for 6 months.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Phase II Double-Blind Randomized Placebo-Controlled Trial of Combination Therapy to Treat COVID-19 Infection
Estimated Study Start Date : September 2020
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : April 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active Arm
Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C
Drug: Ivermectin
Treatment day 1 and day 4
Other Name: Soolantra, Stromectol, Sklice

Drug: Doxycycline Hcl
10 day treatment
Other Name: Doxy-100, Monodox, Oracea, Targadox, Acticlate, Morgidox, Avidoxy, Doryx MPC, Mondoxyne NL, Dory

Dietary Supplement: Zinc
10 Day treatment
Other Name: Zinc sulphate

Dietary Supplement: Vitamin D3
10 day treatment
Other Name: cholecalciferol-D3

Dietary Supplement: Vitamin C
10 day treatment
Other Name: L-ascorbic acid

Placebo Comparator: Placebo
Placebo and Vitamin D3, Vitamin C, and Zinc
Dietary Supplement: Zinc
10 Day treatment
Other Name: Zinc sulphate

Dietary Supplement: Vitamin D3
10 day treatment
Other Name: cholecalciferol-D3

Dietary Supplement: Vitamin C
10 day treatment
Other Name: L-ascorbic acid




Primary Outcome Measures :
  1. Time to Non-Infectivity by RT-PCR [ Time Frame: 6 months ]
    Time to negative RT-PRC result indicating that patient is no longer infective

  2. Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score) [ Time Frame: 6 months ]
    Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.

  3. Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score) [ Time Frame: 6 months ]
    Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.

  4. Efficacy of Treatment as measured by Titer [ Time Frame: 6 months ]
    Patients will have serum stored for titer testing to compare antibody levels over time

  5. Efficacy of Treatment as measured by RT-PCR [ Time Frame: 10 days ]
    Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatment


Secondary Outcome Measures :
  1. Safety of Treatment as Measured by D-Dimer [ Time Frame: 6 Months ]
    Blood D-Dimer levels

  2. Safety of Treatment as Measured by Pro-Calcitonin [ Time Frame: 6 Months ]
    Blood Pro-Calcitonin levels

  3. Safety of Treatment as Measured by C-Reactive Protein [ Time Frame: 6 Months ]
    Blood CRP levels

  4. Safety of Treatment as Measured by Ferritin [ Time Frame: 6 Months ]
    Blood ferritin levels

  5. Safety of Treatment as Measured by Liver Enzymes [ Time Frame: 6 Months ]
    Blood enzyme levels

  6. Safety of Treatment as Measured by Complete Blood Count [ Time Frame: 6 Months ]
    CBC

  7. Safety of Treatment as Measured by Electrolyte Levels [ Time Frame: 6 Months ]
    Blood electrolytes

  8. Safety of Treatment as Measured by Treatment Related Adverse Events [ Time Frame: 6 months ]
    Presence or absence of Grade 3 or high treatment related adverse events



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 to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study
  2. Healthy male or female subjects 18 years of age to 75 years of age
  3. Diabetic and obese (BMI > 30) patients will be included in the Trial but randomization will be stratified.
  4. Positive test for COVID-19 by RT-PCR at screening
  5. Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study. One of these must be a barrier method. Exceptions for females and partners of females that are not of childbearing potential. (e.g. surgically sterilized, post-menopausal)
  6. Subjects must agree they will attend the treatment facility daily for 10d in the event of failure to attend, the patient will be visited at their home to collect the nasal swab and review data.

Exclusion Criteria:

  1. Refusal to sign informed consent form
  2. Negative test for COVID-19 by RT-PCR at screening
  3. Severe disease symptomatically including pneumonia, respiratory distress, tachypnoea, shortness of breath, temperature > 38 degrees C (100.4 degrees F), pleuritic pain, or frequent cough.
  4. Known drug allergy to any of the investigational medications
  5. Currently taking medication with known drug interactions with investigational medications, found in Appendix II
  6. Prescription or other antiviral medications
  7. Any comorbidities which constitute health risk for the subject including known cardiac arrhythmias - but will be limited to those on hydroxychloroquine
  8. Inability to attend daily for 10 days

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): NCT04482686


Contacts
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Contact: Thomas Borody, MD +61-2-9713 4011 RECEPTION@CDD.COM.AU
Contact: Jordan Daniels, MS 805-339-0549 jordan@progenabiome.com

Locations
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United States, California
ProgenaBiome
Ventura, California, United States, 93003
Contact: Sabine Hazan, MD    805-339-0549    drsabinehazan@progenabiome.com   
Contact: Jordan Daniels, MS    805-339-0549    jordan@progenabiome.com   
Principal Investigator: Sabine Hazan, MD         
Sponsors and Collaborators
ProgenaBiome
Topelia Therapeutics
Investigators
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Study Director: Sabine Hazan, MD ProgenaBiome
Study Director: Thomas Borody, MD Topelia Therpeutics
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Responsible Party: ProgenaBiome
ClinicalTrials.gov Identifier: NCT04482686    
Other Study ID Numbers: PRG-049
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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.: No
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Coronavirus Infections
Severe Acute Respiratory Syndrome
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vitamin D
Cholecalciferol
Vitamins
Ascorbic Acid
Zinc
Doxycycline
Ivermectin
Zinc Sulfate
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Trace Elements
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Anti-Bacterial Agents
Anti-Infective Agents