A Study of Quintuple Therapy to Treat COVID-19 Infection
NCT ID: NCT04334512
Last Updated: 2024-02-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
118 participants
INTERVENTIONAL
2020-06-22
2024-02-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Quintuple Therapy
Patients will be treated with quintuple therapy for 10 days.
Hydroxychloroquine
Treatment with hydroxychloroquine
Azithromycin
Treatment with azithromycin
Vitamin C
Treatment with vitamin C
Vitamin D
Treatment with vitamin D
Zinc
Treatment with Zinc
Placebo
Patients will be treated with placebo.
Vitamin C
Treatment with vitamin C
Vitamin D
Treatment with vitamin D
Zinc
Treatment with Zinc
Interventions
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Hydroxychloroquine
Treatment with hydroxychloroquine
Azithromycin
Treatment with azithromycin
Vitamin C
Treatment with vitamin C
Vitamin D
Treatment with vitamin D
Zinc
Treatment with Zinc
Other Intervention Names
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Eligibility Criteria
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Exclusion Criteria
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
18 Years
ALL
No
Sponsors
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DSCS CRO
INDUSTRY
ProgenaBiome
OTHER
Responsible Party
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Principal Investigators
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Sabine Hazan, MD
Role: PRINCIPAL_INVESTIGATOR
ProgenaBiome
Locations
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ProgenaBiome
Ventura, California, United States
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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PRG-044
Identifier Type: -
Identifier Source: org_study_id
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