Trial of Combination Therapy to Treat COVID-19 Infection

Sponsor
ProgenaBiome (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04482686
Collaborator
Topelia Therapeutics (Other)
31
Enrollment
1
Location
2
Arms
18.7
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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 DiseaseIntervention/TreatmentPhase
  • Drug: Ivermectin
  • Drug: Doxycycline Hcl
  • Dietary Supplement: Zinc
  • Dietary Supplement: Vitamin D3
  • Dietary Supplement: Vitamin C
Phase 1

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 an additional 20 days.

Study Design

Study Type:
Interventional
Actual Enrollment :
31 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Phase I Double-Blind Randomized Placebo-Controlled Trial of Combination Therapy to Treat COVID-19 Infection
Actual Study Start Date :
Dec 9, 2020
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

ArmIntervention/Treatment
Experimental: Active Arm

Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C

Drug: Ivermectin
Treatment days 1, 4, and 8
Other Names:
  • Soolantra, Stromectol, Sklice
  • Drug: Doxycycline Hcl
    10 day treatment
    Other Names:
  • Doxy-100, Monodox, Oracea, Targadox, Acticlate, Morgidox, Avidoxy, Doryx MPC, Mondoxyne NL, Dory
  • Dietary Supplement: Zinc
    10 Day treatment
    Other Names:
  • Zinc sulphate
  • Dietary Supplement: Vitamin D3
    10 day treatment
    Other Names:
  • cholecalciferol-D3
  • Dietary Supplement: Vitamin C
    10 day treatment
    Other Names:
  • L-ascorbic acid
  • Placebo Comparator: Placebo

    Placebo and Vitamin D3, Vitamin C, and Zinc

    Dietary Supplement: Zinc
    10 Day treatment
    Other Names:
  • Zinc sulphate
  • Dietary Supplement: Vitamin D3
    10 day treatment
    Other Names:
  • cholecalciferol-D3
  • Dietary Supplement: Vitamin C
    10 day treatment
    Other Names:
  • L-ascorbic acid
  • Outcome Measures

    Primary Outcome Measures

    1. Time to Non-Infectivity by RT-PCR [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) [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) [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 [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 [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 [6 Months]

      Blood D-Dimer levels

    2. Safety of Treatment as Measured by Pro-Calcitonin [6 Months]

      Blood Pro-Calcitonin levels

    3. Safety of Treatment as Measured by C-Reactive Protein [6 Months]

      Blood CRP levels

    4. Safety of Treatment as Measured by Ferritin [6 Months]

      Blood ferritin levels

    5. Safety of Treatment as Measured by Liver Enzymes [6 Months]

      Blood enzyme levels

    6. Safety of Treatment as Measured by Complete Blood Count [6 Months]

      CBC

    7. Safety of Treatment as Measured by Electrolyte Levels [6 Months]

      Blood electrolytes

    8. Safety of Treatment as Measured by Treatment Related Adverse Events [6 months]

      Presence or absence of Grade 3 or high treatment related adverse events

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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 at least 18 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 or rapid antigen test 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, tachypnea, shortness of breath, temperature > 104.0 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

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1ProgenaBiomeVenturaCaliforniaUnited States93003

    Sponsors and Collaborators

    • ProgenaBiome
    • Topelia Therapeutics

    Investigators

    • Study Director: Sabine Hazan, MD, ProgenaBiome
    • Study Director: Thomas Borody, MD, Topelia Therpeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    ProgenaBiome
    ClinicalTrials.gov Identifier:
    NCT04482686
    Other Study ID Numbers:
    • PRG-049
    First Posted:
    Jul 22, 2020
    Last Update Posted:
    Nov 2, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:

    Study Results

    No Results Posted as of Nov 2, 2021