Clinical trial NCT04334512: A Study of Quintuple Therapy to Treat COVID-19 Infection
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COVID-19
Corona Virus Infection
Coronavirus-19
Sars-CoV2
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
Collaborators: name: DSCS CRO
First posted: 2020-04-06
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a Randomized, Double-Blind, Placebo-Controlled Phase II interventional Study
Primary purpose: TREATMENT

Brief summary: This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).

Detailed description: In this study patients will be treated with a combination therapy to determine if this combination can effectively treat COVID-19. Treatment will last ten days. The study will last 24 weeks.

Eligibility criteria: 1. Informed consent provided electronically via the EDC, demonstrating that the subject understands the procedures required for the study and the purpose of the study
2. Male or female subjects 18 years of age and up
3. Subjects must agree to practice at least two highly effective methods 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. At least one of these must be a barrier method. Subjects not of reproductive potential will be exempt (e.g. post-menopausal, surgically sterilized)
4. Diagnosis of COVID-19 by RT-PCR

Exclusion Criteria

1. Refusal to provide informed consent
2. Diarrhea prior to infection
3. Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject
4. 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
5. Anemia from pyruvate kinase and G6PD deficiencies
6. Abnormal EKG with QT prolongation acquired or from birth
7. Allergies to 4-Aminoquinolines
8. History of jaundice or high fevers prior to developing COVID-19
9. Treatment with any of the medications listed in Appendix II
10. Treatment with any other drug not listed that affects the QT interval
11. Treatment with any anti-epileptic drug, whether prescribed for seizures or otherwise.
12. Pregnant or breastfeeding women

Primary outcomes:
measure: The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy
timeFrame: 12 weeks
measure: Reduction or Progression of Symptomatic Days
timeFrame: 12 weeks
measure: Assess the safety of Quintuple Therapy
timeFrame: 12 weeks
measure: Assess the safety of Quintuple Therapy via pulse
timeFrame: 12 weeks
measure: Assess the safety of Quintuple Therapy via oxygen saturation
timeFrame: 12 weeks
measure: Assess the safety of Quintuple Therapy via EKG
timeFrame: 12 weeks
measure: Assess Tolerability of Quintuple Therapy
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Banjanac M, Munic Kos V, Nujic K, Vrancic M, Belamaric D, Crnkovic S, Hlevnjak M, Erakovic Haber V. Anti-inflammatory mechanism of action of azithromycin in LPS-stimulated J774A.1 cells. Pharmacol Res. 2012 Oct;66(4):357-62. doi: 10.1016/j.phrs.2012.06.011. Epub 2012 Jul 3.
citation: Cortegiani A, Ingoglia G, Ippolito M, Giarratano A, Einav S. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020 Jun;57:279-283. doi: 10.1016/j.jcrc.2020.03.005. Epub 2020 Mar 10.
citation: Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73. doi: 10.5582/bst.2020.01047. Epub 2020 Feb 19.
citation: Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.
citation: Zhang L, Liu Y. Potential interventions for novel coronavirus in China: A systematic review. J Med Virol. 2020 May;92(5):479-490. doi: 10.1002/jmv.25707. Epub 2020 Mar 3.