A Study of Combination Therapies to Treat COVID-19 Infection

NCT04459702 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: PRG-043
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This study seeks to determine whether dual or quadruple therapy is more effective in treating COVID-19.

Conditions

COVID; COVID-19; Corona Virus Infection; Coronavirus Infection; Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere; Coronavirus-19; SARS-CoV 2; SARS Pneumonia

Outcome Measures

Primary Outcomes (2)

• Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores

  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 by Time to Non-Infectivity

  Time to non-infectivity as measured by PCR testing

  10 days

Secondary Outcomes (38)

• Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores

  6 months

• Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores.

  6 months

• Safety of Dual Therapy as Measured by Complete Blood Count

  6 months

• Safety of Quadruple Therapy as Measured by Complete Blood Count

  6 months

• Safety of Dual Therapy as Measured by Metabolic Panel -Albumin

  6 months

Study Arms (2)

Dual Therapy

EXPERIMENTAL

Dual Therapy utilizing hydroxychloroquine and azithromycin.

Drug: hydroxychloroquine; Drug: Azithromycin

Quadruple Therapy

EXPERIMENTAL

Quadruple therapy utilizing hydroxychloroquine, lopinavir, ritonavir, and azithromycin

Drug: hydroxychloroquine; Drug: Azithromycin; Drug: Ritonavir; Drug: Lopinavir

Interventions

hydroxychloroquine DRUG

Treatment with the drug hydroxychloroquine

Also known as: Plaquenil

Dual Therapy; Quadruple Therapy

Azithromycin DRUG

Treatment with the drug azithromycin

Also known as: Zithromax

Dual Therapy; Quadruple Therapy

Ritonavir DRUG

Treatment with the drug ritonavir

Also known as: norvir

Quadruple Therapy

Lopinavir DRUG

Treatment with the drug lopinavir

Quadruple Therapy

Eligibility Criteria

• Age: 18 Years - 65 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, ambulant male or female subjects 18 years of age to 65 years of age
• Positive test for COVID-19 by RT-PCR at screening
• Subjects must agree to practice at least one highly effective method of birth control for the duration of the study. This includes condoms with spermicide, oral birth control pills, contraceptive implants, intra-uterine devices, or diaphragms. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized)
• Subjects must agree they will do their best to attend the treatment facility daily for 10 days

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 \> 38 degrees; pleuritic pain, or frequent cough.
• Known drug allergy to any of the investigational medications
• Currently taking medication with known drug interactions with investigational medications (listed in appendix)
• Prescription or other antiviral medications
• Any comorbidities which constitute health risk for the subject
• Pregnant or lactating females;
• weight \< 110lb;
• porphyria
• established retinal disease
• Inability to attend daily for 10 days
• Any contraindications for treatment with hydroxychloroquine
• Hypoglycemia
• Known G6PD deficiency

Sponsors & Collaborators

• ProgenaBiome: lead
• Big Corona Ltd.: collaborator

Study Sites (1)

ProgenaBiome

Ventura, California, 93003, United States

Location

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Hydroxychloroquine; Azithromycin; Ritonavir; Lopinavir

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)

Chloroquine; Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; Organic Chemicals; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Pyrimidinones; Pyrimidines

Study Officials

• Sabine Hazan, MD

  ProgenaBiome

  PRINCIPAL INVESTIGATOR

• Thomas Borody, MD, PhD,

  Big Corona Ltd.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2020
• First Posted: July 7, 2020
• Study Start: July 1, 2020
• Primary Completion: July 1, 2021
• Study Completion: December 1, 2021
• Last Updated: April 8, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)