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Completed

NCT Number: NCT04482686

Trial of Combination Therapy to Treat COVID-19 Infection

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study
  • Healthy male or female subjects at least 18 years of age
  • Diabetic and obese (BMI > 30) patients will be included in the Trial but randomization will be stratified.
  • Positive test for COVID-19 by RT-PCR or rapid antigen test at screening
  • 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)
  • 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

  • Refusal to sign informed consent form
  • Negative test for COVID-19 by RT-PCR at screening
  • Severe disease symptomatically including pneumonia, respiratory distress, tachypnea, shortness of breath, temperature > 104.0 degrees F, pleuritic pain, or frequent cough.
  • Known drug allergy to any of the investigational medications
  • Currently taking medication with known drug interactions with investigational medications, found in Appendix II
  • Prescription or other antiviral medications
  • Any comorbidities which constitute health risk for the subject including known cardiac arrhythmias - but will be limited to those on hydroxychloroquine
  • Inability to attend daily for 10 days

Treatment and study plan

Ivermectin

Drug

Treatment days 1, 4, and 8

Other names: Soolantra, Stromectol, Sklice

Doxycycline Hcl

Drug

10 day treatment

Other names: Doxy-100, Monodox, Oracea, Targadox, Acticlate, Morgidox, Avidoxy, Doryx MPC, Mondoxyne NL, Dory

Zinc

Dietary Supplement

10 Day treatment

Other names: Zinc sulphate

Vitamin D3

Dietary Supplement

10 day treatment

Other names: cholecalciferol-D3

Vitamin C

Dietary Supplement

10 day treatment

Other names: L-ascorbic acid

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

ProgenaBiome

Other

Registry information

Official study title

A Phase I Double-Blind Randomized Placebo-Controlled Trial of Combination Therapy to Treat COVID-19 Infection

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 22, 2020
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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