Clinical trial NCT04459702: A Study of Combination Therapies to Treat COVID-19 Infection
Official title: A Phase IIa Randomized, Controlled Study of Combination Therapies to Treat COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
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
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
Collaborators: name: Big Corona Ltd.
First posted: 2020-07-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed description: In this study, patients will be administered either dual or quadruple therapy and have PCR tests run daily to determine efficacy as indicated by time to non-infectivity

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study
2. Healthy, ambulant male or female subjects 18 years of age to 65 years of age
3. Positive test for COVID-19 by RT-PCR at screening
4. 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)
5. Subjects must agree they will do their best to attend the treatment facility daily for 10 days

Exclusion Criteria:

1. Refusal to sign informed consent form
2. Negative test for COVID-19 by RT-PCR at screening
3. Severe disease symptomatically including pneumonia, respiratory distress, tachypnea, shortness of breath, temperature \> 38 degrees; pleuritic pain, or frequent cough.
4. Known drug allergy to any of the investigational medications
5. Currently taking medication with known drug interactions with investigational medications (listed in appendix)
6. Prescription or other antiviral medications
7. Any comorbidities which constitute health risk for the subject
8. Pregnant or lactating females;
9. weight \< 110lb;
10. porphyria
11. established retinal disease
12. Inability to attend daily for 10 days
13. Any contraindications for treatment with hydroxychloroquine

    1. Hypoglycemia
    2. Known G6PD deficiency
    3. Porphyria
    4. Anemia
    5. Neutropenia
    6. Alcoholism
    7. Myasthenia gravis
    8. Skeletal muscle disorders
    9. Maculopathy
    10. Changes in visual field
    11. Liver disease
    12. Psoriasis
    13. History of QT \>500msec
    14. History of torsades de pointes
14. Anemia from pyruvate kinase and G6PD deficiencies
15. Abnormal EKG with QT prolongation acquired or from birth
16. History of jaundice or high fevers prior to developing COVID-19
17. Treatment with any of the medications listed in Appendix II
18. Treatment with any anti-epileptic medication
19. Treatment with any other drug not listed that affects the QT interval

Primary outcomes:
measure: Efficacy of Treatment by Reduced Symptoms NEWS (National Early Warning System) scores
timeFrame: 6 months
measure: Efficacy of Treatment by Time to Non-Infectivity
timeFrame: 10 days
Secondary outcomes:
measure: Safety of Dual Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) sores
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Symptoms rated on the NEWS (National Early Warning System) scores.
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Complete Blood Count
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Complete Blood Count
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Metabolic Panel -Albumin
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Albumin
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - A/G Ratio
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Metabolic Panel A/G Ratio
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Alkaline Phosphatase
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Metabolic Panel Alkaline Phosphatase
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Metabolic Panel - AST
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - AST
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - ALT
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Metabolic Panel ALT
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel BUN/Creatinine Ratio
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - BUN
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Metabolic Panel - BUN
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Calcium
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Calcium
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Carbon Dioxide
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Carbon Dioxide
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Chloride
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Chloride
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Creatinine
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Creatinine
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Globulin
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Globulin
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Glucose
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Glucose
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Potassium
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Potassium
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Bilirubin
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Total Bilirubin
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Metabolic Panel - Total Protein
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Metabolic Panel - Total Protein
timeFrame: 6 months
measure: Safety of Dual Therapy as Measured by Treatment Related SAE
timeFrame: 6 months
measure: Safety of Quadruple Therapy as Measured by Treatment Related SAE
timeFrame: 6 months
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Big Corona Ltd.
name: Thomas Borody, MD, PhD,
role: PRINCIPAL_INVESTIGATOR
References: