A Study of Combination Therapies to Treat COVID-19 Infection

ProgenaBiome

Status and phase: Withdrawn; Phase 2

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04459702

PRG-043

Details and patient eligibility

About

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

Full 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

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

Dual Therapy

Experimental group

Description:

Dual Therapy utilizing hydroxychloroquine and azithromycin.

Treatment:

Drug: hydroxychloroquine

Drug: Azithromycin

Quadruple Therapy

Experimental group

Description:

Quadruple therapy utilizing hydroxychloroquine, lopinavir, ritonavir, and azithromycin

Treatment:

Drug: Ritonavir

Drug: hydroxychloroquine

Drug: Lopinavir

Drug: Azithromycin