Study Summary
This trial is testing whether a combination of hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19.
Eligible Conditions
- Coronavirus
- COVID-19
- Coronavirus Infection
- Coronavirus Disease (COVID-19)
Treatment Effectiveness
Effectiveness Progress
Study Objectives
2 Primary · 0 Secondary · Reporting Duration: 24 weeks
24 weeks
Prevention of COVID-19 symptoms as recorded in a daily diary
Safety as determined by presence or absence of Adverse Events and Serious Adverse Events
Trial Safety
Safety Progress
This is further along than 68% of similar trials
Side Effects for
Sarilumab 150 mg by PFS (Extension Phase)
13%Upper respiratory tract infection
6%Neutropenia
6%Sinusitis
5%Alanine aminotransferase increased
5%Urinary tract infection
4%Injection site erythema
4%Accidental overdose
4%Bronchitis
3%Injection site pruritus
2%Nasopharyngitis
2%Thrombocytopenia
2%Contusion
1%Small intestinal obstruction
1%Vertebrobasilar insufficiency
1%Thrombophlebitis superficial
1%Lumbar spinal stenosis
1%Chronic obstructive pulmonary disease
1%Arthralgia
1%Traumatic arthritis
1%Nephrolithiasis
1%Hypertension
1%Transient ischaemic attack
1%Vomiting
1%Endometrial hyperplasia
1%Cataract
1%Pneumonia
1%Anaemia
1%Pancreatic carcinoma metastatic
1%Wolff-Parkinson-White syndrome
1%Coronary artery occlusion
1%Osteoarthritis
1%Rheumatoid lung
1%Pharyngitis
1%Femoral neck fracture
1%Leukopenia
Trial Design
2 Treatment Groups
Medical Workers
1 of 2
Placebo
1 of 2
Experimental Treatment
Non-Treatment Group
600 Total Participants · 2 Treatment Groups
Primary Treatment: Hydroxychloroquine · Has Placebo Group · Phase 2
Medical WorkersExperimental Group · 4 Interventions: Vitamin D, Vitamin C, Zinc, Hydroxychloroquine · Intervention Types: DietarySupplement, DietarySupplement, DietarySupplement, Drug
PlaceboPlaceboComparator Group · 3 Interventions: Vitamin D, Vitamin C, Zinc · Intervention Types: DietarySupplement, DietarySupplement, DietarySupplement
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vitamin D
2013
Completed Phase 4
~3470
Vitamin C
2017
Completed Phase 4
~18410
Zinc
2005
Completed Phase 4
~17050
Hydroxychloroquine
FDA approved
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks
Who is running the clinical trial?
ProgenaBiomeLead Sponsor
44 Previous Clinical Trials
5,212 Total Patients Enrolled
DSCS CROIndustry Sponsor
2 Previous Clinical Trials
618 Total Patients Enrolled
Sabine Hazan, MDPrincipal InvestigatorProgenaBiome
40 Previous Clinical Trials
4,911 Total Patients Enrolled
Eligibility Criteria
Age 18+ · All Participants · 4 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You are 18 years or older and have a higher risk of developing the condition being studied.
References
- Cortegiani, Andrea, Giulia Ingoglia, Mariachiara Ippolito, Antonino Giarratano, and Sharon Einav. 2020. “A Systematic Review on the Efficacy and Safety of Chloroquine for the Treatment of COVID-19”. Journal of Critical Care. Elsevier BV. doi:10.1016/j.jcrc.2020.03.005.
- Gautret, Philippe, Jean-Christophe Lagier, Philippe Parola, Van Thuan Hoang, Line Meddeb, Morgane Mailhe, Barbara Doudier, et al.. 2020. “Hydroxychloroquine and Azithromycin as a Treatment of COVID-19: Results of an Open-label Non-randomized Clinical Trial”. International Journal of Antimicrobial Agents. Elsevier BV. doi:10.1016/j.ijantimicag.2020.105949.
- Banjanac, Mihailo, Vesna Munić Kos, Krunoslav Nujić, Mila Vrančić, Daniela Belamarić, Slaven Crnković, Mario Hlevnjak, and Vesna Eraković Haber. 2012. “Anti-inflammatory Mechanism of Action of Azithromycin in Lps-stimulated J774A.1 Cells”. Pharmacological Research. Elsevier BV. doi:10.1016/j.phrs.2012.06.011.
- Gao, Jianjun, Zhenxue Tian, and Xu Yang. 2020. “Breakthrough: Chloroquine Phosphate Has Shown Apparent Efficacy in Treatment of COVID-19 Associated Pneumonia in Clinical Studies”. Bioscience Trends. International Research and Cooperation Association for Bio & Socio-Sciences Advancement (IRCA-BSSA). doi:10.5582/bst.2020.01047.
- Zhang, Lei, and Yunhui Liu. 2020. “Potential Interventions for Novel Coronavirus in China: A Systematic Review”. Journal of Medical Virology. Wiley. doi:10.1002/jmv.25707.
- 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.
- 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.
- 2020. "A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04335084.
Frequently Asked Questions
Are there any opportunities for participants to join this experiment presently?
"Clinicaltrials.gov reports that this medical trial, which began recruiting on June 22nd 2020, is still actively seeking patients. The last update to the study was made in October of 2021." - Anonymous Online Contributor
Unverified Answer
What is the current participant count in this clinical experiment?
"Affirmative. Clinicaltrials.gov has verified that this investigation, which was initially made available on June 22nd 2020, is in the process of recruiting volunteers. 600 participants must be gathered from 1 medical hub to successfully complete the trial." - Anonymous Online Contributor
Unverified Answer
Does the FDA certify Hydroxychloroquine as safe and effective?
"Hydroxychloroquine has been graded a 2 by our team at Power, as there is evidence that it can be used safely but no confirmation of its efficacy." - Anonymous Online Contributor
Unverified Answer
To what ailments is hydroxychloroquine typically prescribed?
"Hydroxychloroquine is a treatment option for three different ailments: malaria, q fever, and rheumatoid arthritis." - Anonymous Online Contributor
Unverified Answer