Trial | NCT04482686  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    31
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.
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 Started
Dec 09
2020
Primary Completion
May 31
2022
Anticipated
Study Completion
Jul 31
2022
Anticipated
Last Update
Nov 02
2021

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

Active Arm Experimental

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

Placebo Placebo Comparator

Placebo and Vitamin D3, Vitamin C, and Zinc

Criteria 

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
No Results Posted