Trial of Combination Therapy to Treat COVID-19 Infection

NCT04482686 | Completed Phase 1 DMC FDA Drug

• 1 other identifier: PRG-049
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID; Covid-19; Corona Virus Infection; Coronavirus Infection; Coronavirus-19; SARS-CoV2; SARS-CoV Infection

Outcome Measures

Primary Outcomes (5)

• Time to Non-Infectivity by RT-PCR

  Time to negative RT-PRC result indicating that patient is no longer infective

  6 months

• Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score)

  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.

  6 months

• Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score)

  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.

  6 months

• Efficacy of Treatment as measured by Titer

  Patients will have serum stored for titer testing to compare antibody levels over time

  6 months

• Efficacy of Treatment as measured by RT-PCR

  Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatment

  10 days

Secondary Outcomes (8)

• Safety of Treatment as Measured by D-Dimer

  6 Months

• Safety of Treatment as Measured by Pro-Calcitonin

  6 Months

• Safety of Treatment as Measured by C-Reactive Protein

  6 Months

• Safety of Treatment as Measured by Ferritin

  6 Months

• Safety of Treatment as Measured by Liver Enzymes

  6 Months

Study Arms (2)

Active Arm

EXPERIMENTAL

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

Drug: Ivermectin; Drug: Doxycycline Hcl; Dietary Supplement: Zinc; Dietary Supplement: Vitamin D3; Dietary Supplement: Vitamin C

Placebo

PLACEBO COMPARATOR

Placebo and Vitamin D3, Vitamin C, and Zinc

Dietary Supplement: Zinc; Dietary Supplement: Vitamin D3; Dietary Supplement: Vitamin C

Interventions

Ivermectin DRUG

Treatment days 1, 4, and 8

Also known as: Soolantra, Stromectol, Sklice

Active Arm

Doxycycline Hcl DRUG

10 day treatment

Also known as: Doxy-100, Monodox, Oracea, Targadox, Acticlate, Morgidox, Avidoxy, Doryx MPC, Mondoxyne NL, Dory

Active Arm

Zinc DIETARY_SUPPLEMENT

10 Day treatment

Also known as: Zinc sulphate

Active Arm; Placebo

Vitamin D3 DIETARY_SUPPLEMENT

10 day treatment

Also known as: cholecalciferol-D3

Active Arm; Placebo

Vitamin C DIETARY_SUPPLEMENT

10 day treatment

Also known as: L-ascorbic acid

Active Arm; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• ProgenaBiome: lead

Study Sites (1)

ProgenaBiome

Ventura, California, 93003, United States

Location

Related Publications (2)

• Hazan S, Vidal AC, Hulscher N, Goudzwaard A, McCullough PA, Steinberg AA. Cardiac findings in a phase II double-blind randomized placebo-controlled trial of combination therapy (HAZDPac) to treat COVID-19 patients. BMC Cardiovasc Disord. 2024 Dec 19;24(1):710. doi: 10.1186/s12872-024-04376-y.

  PMID: 39702045 DERIVED

• Hazan S, Dave S, Gunaratne AW, Dolai S, Clancy RL, McCullough PA, Borody TJ. Effectiveness of ivermectin-based multidrug therapy in severely hypoxic, ambulatory COVID-19 patients. Future Microbiol. 2022 Mar;17:339-350. doi: 10.2217/fmb-2022-0014. Epub 2022 Feb 9.

  PMID: 35135310 DERIVED

MeSH Terms

Conditions

COVID-19; Coronavirus Infections; Severe Acute Respiratory Syndrome

Interventions

Ivermectin; Doxycycline; Zinc; Zinc Sulfate; Cholecalciferol; Ascorbic Acid

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals; Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Zinc Compounds; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Sugar Acids; Acids, Acyclic; Carboxylic Acids; Hydroxy Acids; Carbohydrates

Study Officials

• Sabine Hazan, MD

  ProgenaBiome

  STUDY DIRECTOR

• Thomas Borody, MD

  Topelia Therpeutics

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2020
• First Posted: July 22, 2020
• Study Start: December 9, 2020
• Primary Completion: May 15, 2022
• Study Completion: July 15, 2022
• Last Updated: September 24, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)