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| Name | Class |
|---|---|
| DSCS CRO | INDUSTRY |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quintuple Therapy | Experimental | Patients will be treated with quintuple therapy for 10 days. |
|
| Placebo | Placebo Comparator | Patients will be treated with placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | Treatment with hydroxychloroquine |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Reduction or Progression of Symptomatic Days | Reduction and/or progression of symptomatic days, reduction of symptom severity | 12 weeks |
| Assess the safety of Quintuple Therapy | Assess the symptom response to study therapy as measured by the survey in the EDC | 12 weeks |
| Assess the safety of Quintuple Therapy via pulse | Pulse from baseline to 12 weeks | 12 weeks |
| Assess the safety of Quintuple Therapy via oxygen saturation | Oxygen saturation from baseline to 12 weeks | 12 weeks |
| Assess the safety of Quintuple Therapy via EKG | EKG response from baseline to 12 weeks | 12 weeks |
| Assess Tolerability of Quintuple Therapy | Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy | 12 weeks |
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Exclusion Criteria
Refusal to provide informed consent
Diarrhea prior to infection
Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject
Any contraindications for treatment with hydroxychloroquine
Anemia from pyruvate kinase and G6PD deficiencies
Abnormal EKG with QT prolongation acquired or from birth
Allergies to 4-Aminoquinolines
History of jaundice or high fevers prior to developing COVID-19
Treatment with any of the medications listed in Appendix II
Treatment with any other drug not listed that affects the QT interval
Treatment with any anti-epileptic drug, whether prescribed for seizures or otherwise.
Pregnant or breastfeeding women
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| Name | Affiliation | Role |
|---|---|---|
| Sabine Hazan, MD | ProgenaBiome | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ProgenaBiome | Ventura | California | 93003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22766077 | Background | 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. | |
| 32173110 | Background | 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. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 20, 2025 | Jul 8, 2025 | 9 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| D017963 | Azithromycin |
| D001205 | Ascorbic Acid |
| D014807 | Vitamin D |
| D015032 | Zinc |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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This is a Randomized, Double-Blind, Placebo-Controlled Phase II interventional Study
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| Azithromycin | Drug | Treatment with azithromycin |
|
|
| Vitamin C | Dietary Supplement | Treatment with vitamin C |
|
| Vitamin D | Dietary Supplement | Treatment with vitamin D |
|
| Zinc | Dietary Supplement | Treatment with Zinc |
|
| 32074550 | Background | 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. |
| 32205204 | Background | 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. |
| 32052466 | Background | 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. |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D004917 | Erythromycin |
| D018942 | Macrolides |
| D061065 | Polyketides |
| D007783 | Lactones |
| D009930 | Organic Chemicals |
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D006880 | Hydroxy Acids |
| D002241 | Carbohydrates |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D019216 | Metals, Heavy |
| D004602 | Elements |
| D007287 | Inorganic Chemicals |
| D028561 | Transition Elements |
| D008670 | Metals |