A Study of Quintuple Therapy to Treat COVID-19 Infection

COVID-19 Clinical Trial

— HAZDpaC  

Official title:

A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04334512
• Other study ID #: PRG-044
• Status: Completed
• Phase: Phase 2
• Start date: June 22, 2020
• Est. completion date: February 27, 2024

Study information

• Verified date: February 2024
• Source: ProgenaBiome
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: February 27, 2024
• Est. primary completion date: February 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Corona Virus Infection
• Coronavirus Infections
• Coronavirus-19
• COVID-19
• Infections
• Sars-CoV2

Intervention

Drug:
• Hydroxychloroquine
Treatment with hydroxychloroquine
• Azithromycin
Treatment with azithromycin

Dietary Supplement:
• Vitamin C
Treatment with vitamin C
• Vitamin D
Treatment with vitamin D
• Zinc
Treatment with Zinc

Locations

Country	Name	City	State
United States	ProgenaBiome	Ventura	California

Sponsors (2)

Lead Sponsor	Collaborator
ProgenaBiome	DSCS CRO

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View 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. — View 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. — View 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. 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy	Number of days from COVID-19 diagnosis to recovery via RT-PCR	12 weeks
Primary	Reduction or Progression of Symptomatic Days	Reduction and/or progression of symptomatic days, reduction of symptom severity	12 weeks
Primary	Assess the safety of Quintuple Therapy	Assess the symptom response to study therapy as measured by the survey in the EDC	12 weeks
Primary	Assess the safety of Quintuple Therapy via pulse	Pulse from baseline to 12 weeks	12 weeks
Primary	Assess the safety of Quintuple Therapy via oxygen saturation	Oxygen saturation from baseline to 12 weeks	12 weeks
Primary	Assess the safety of Quintuple Therapy via EKG	EKG response from baseline to 12 weeks	12 weeks
Primary	Assess Tolerability of Quintuple Therapy	Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy	12 weeks