A Study of Combination Therapies to Treat COVID-19 Infection
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ClinicalTrials.gov Identifier: NCT04459702 |
Recruitment Status :
Withdrawn
(Was never started)
First Posted : July 7, 2020
Last Update Posted : April 8, 2021
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Condition or disease | Intervention/treatment | Phase |
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COVID COVID-19 Corona Virus Infection Coronavirus Infection Coronavirus Sars-Associated as Cause of Disease Classified Elsewhere Coronavirus-19 SARS-CoV 2 SARS Pneumonia | Drug: hydroxychloroquine Drug: Azithromycin Drug: Ritonavir Drug: Lopinavir | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 0 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Phase IIa Randomized, Controlled Study of Combination Therapies to Treat COVID-19 Infection |
Estimated Study Start Date : | July 2020 |
Estimated Primary Completion Date : | July 2021 |
Estimated Study Completion Date : | December 2021 |

Arm | Intervention/treatment |
---|---|
Experimental: Dual Therapy
Dual Therapy utilizing hydroxychloroquine and azithromycin.
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Drug: hydroxychloroquine
Treatment with the drug hydroxychloroquine
Other Name: Plaquenil Drug: Azithromycin Treatment with the drug azithromycin
Other Name: Zithromax |
Experimental: Quadruple Therapy
Quadruple therapy utilizing hydroxychloroquine, lopinavir, ritonavir, and azithromycin
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Drug: hydroxychloroquine
Treatment with the drug hydroxychloroquine
Other Name: Plaquenil Drug: Azithromycin Treatment with the drug azithromycin
Other Name: Zithromax Drug: Ritonavir Treatment with the drug ritonavir
Other Name: norvir Drug: Lopinavir Treatment with the drug lopinavir |
- Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores [ 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.
- Efficacy of Treatment by Time to Non-Infectivity [ Time Frame: 10 days ]Time to non-infectivity as measured by PCR testing
- Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores [ Time Frame: 6 months ]Patient symptoms will be recorded using the NEWS system, which rates 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.
- Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores. [ Time Frame: 6 months ]Patient symptoms will be recorded using the NEWS system, which rates 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.
- Safety of Dual Therapy as Measured by Complete Blood Count [ Time Frame: 6 months ]Changes in blood parameters measured in a Complete Blood Count (CBC).
- Safety of Quadruple Therapy as Measured by Complete Blood Count [ Time Frame: 6 months ]Changes in blood parameters measured in a Complete Metabolic Panel.
- Safety of Dual Therapy as Measured by Metabolic Panel -Albumin [ Time Frame: 6 months ]Changes in serum albumin levels
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin [ Time Frame: 6 months ]Changes in serum albumin levels
- Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio [ Time Frame: 6 months ]Changes in serum albumin/globulin ratio
- Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio [ Time Frame: 6 months ]Changes in serum albumin/globulin ratio
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase [ Time Frame: 6 months ]Changes in serum alkaline phosphatase levels
- Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase [ Time Frame: 6 months ]Changes in serum alkaline phosphatase levels
- Safety of Dual Therapy as Measured by Metabolic Panel - AST [ Time Frame: 6 months ]Changes in serum AST levels
- Safety of Quadruple Therapy as Measured by Metabolic Panel - AST [ Time Frame: 6 months ]Changes in serum AST levels
- Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT [ Time Frame: 6 months ]Changes in serum ALT levels
- Safety of Dual Therapy as Measured by Metabolic Panel ALT [ Time Frame: 6 months ]Changes in serum ALT levels
- Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio [ Time Frame: 6 months ]Changes in serum BUN/Creatinine Ratio
- Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio [ Time Frame: 6 months ]Changes in serum BUN/Creatinine Ratio
- Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN [ Time Frame: 6 months ]Changes in serum Blood Urea Nitrogen levels
- Safety of Dual Therapy as Measured by Metabolic Panel - BUN [ Time Frame: 6 months ]Changes in serum Blood Urea Nitrogen levels
- Safety of Dual Therapy as Measured by Metabolic Panel - Calcium [ Time Frame: 6 months ]Changes in serum calcium levels
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium [ Time Frame: 6 months ]Changes in serum calcium levels
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide [ Time Frame: 6 months ]Changes in serum carbon dioxide levels
- Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide [ Time Frame: 6 months ]Changes in serum carbon dioxide levels
- Safety of Dual Therapy as Measured by Metabolic Panel - Chloride [ Time Frame: 6 months ]Changes in serum chloride levels
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride [ Time Frame: 6 months ]Changes in serum chloride levels
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine [ Time Frame: 6 months ]Changes in serum creatinine levels
- Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine [ Time Frame: 6 months ]Changes in serum creatinine levels
- Safety of Dual Therapy as Measured by Metabolic Panel - Globulin [ Time Frame: 6 months ]Changes in serum globulin levels
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin [ Time Frame: 6 months ]Changes in serum globulin levels
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose [ Time Frame: 6 months ]Changes in blood glucose levels
- Safety of Dual Therapy as Measured by Metabolic Panel - Glucose [ Time Frame: 6 months ]Changes in blood glucose levels
- Safety of Dual Therapy as Measured by Metabolic Panel - Potassium [ Time Frame: 6 months ]Changes in blood potassium levels
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium [ Time Frame: 6 months ]Changes in blood potassium levels
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin [ Time Frame: 6 months ]Changes in serum total bilirubin levels
- Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin [ Time Frame: 6 months ]Changes in serum total bilirubin levels
- Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein [ Time Frame: 6 months ]Changes in serum total protein levels
- Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein [ Time Frame: 6 months ]Changes in serum total protein levels
- Safety of Dual Therapy as Measured by Treatment Related SAE [ Time Frame: 6 months ]Presence or absence of treatment related serious adverse events Grade III or higher
- Safety of Quadruple Therapy as Measured by Treatment Related SAE [ Time Frame: 6 months ]Presence or absence of treatment related serious adverse events Grade III or higher

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
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 > 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
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Any contraindications for treatment with hydroxychloroquine
- Hypoglycemia
- Known G6PD deficiency
- Porphyria
- Anemia
- Neutropenia
- Alcoholism
- Myasthenia gravis
- Skeletal muscle disorders
- Maculopathy
- Changes in visual field
- Liver disease
- Psoriasis
- History of QT >500msec
- History of torsades de pointes
- Anemia from pyruvate kinase and G6PD deficiencies
- Abnormal EKG with QT prolongation acquired or from birth
- History of jaundice or high fevers prior to developing COVID-19
- Treatment with any of the medications listed in Appendix II
- Treatment with any anti-epileptic medication
- Treatment with any other drug not listed that affects the QT interval

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04459702
United States, California | |
ProgenaBiome | |
Ventura, California, United States, 93003 |
Principal Investigator: | Sabine Hazan, MD | ProgenaBiome | |
Principal Investigator: | Thomas Borody, MD, PhD, | Big Corona Ltd. |
Responsible Party: | ProgenaBiome |
ClinicalTrials.gov Identifier: | NCT04459702 |
Other Study ID Numbers: |
PRG-043 |
First Posted: | July 7, 2020 Key Record Dates |
Last Update Posted: | April 8, 2021 |
Last Verified: | April 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
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 |
Infections Communicable Diseases COVID-19 Coronavirus Infections Disease Attributes Pathologic Processes Respiratory Tract Infections Pneumonia, Viral Pneumonia Virus Diseases Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |
Ritonavir Lopinavir Azithromycin Hydroxychloroquine HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors |