COVID-19Phase 2HELPCOVID-19NCT04335084
A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection
A Phase 2 study testing Hydroxychloroquine, Vitamin C and Vitamin D in people with COVID-19 and Coronavirus Infection, run by ProgenaBiome at 1 site in United States.
Trial summary
This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Coronavirus Infection, Sars-CoV2
- What is being tested?
- Hydroxychloroquine, Vitamin C and Vitamin D
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 254 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2020to 11 Apr 2024
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed consent, provided electronically via the EDC, demonstrating the subject understands the procedures required for the study and the purpose of the study
- Male or female patients 18 years of age or older that are considered to be high-risk individuals.
- High-risk individuals are defined as all health care workers in hospitals, clinics, and emergency rooms, and medical facilities.
- 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)
Who cannot join
- Refusal to provide informed consent
- Any previous positive test for COVID-19 by RT-PCR
- Symptomatic for COVID-19
- Diarrhea prior to the start of treatment
- Type I or II diabetes
- Atherosclerotic Coronary Artery Disease
Show all 22Show fewer
- Any contraindication for treatment with hydroxychloroquine including:
- Hypoglycemia
- G6PD deficiency
- Porphyria
- Anemia
- Neutropenia
- Alcoholism
- Myasthenia Gravis
- Skeletal muscle disorder
- Maculopathy
- Changes in the visual field
- Liver disease, with ALT/AST > 2.5 upper limit normal and total bilirubin >2.5 upper limit normal
- Psoriasis
- Any contraindicated medications found in Appendix 2
- Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject.
- Vaccination for SARS-CoV-2
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection
This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19
Read the detailed description
In this study, subjects will take a regimen of hydroxychloroquine, vitamin C, vitamin D, and Zinc to test if this combination can prevent COVID-19. Treatment with hydroxychlorquine will last 1 day. Treatment with vitamin C, vitamin D, and and zinc will last 12 weeks. The study will last 12 weeks.
- Conditions
- COVID-19, Coronavirus Infection, Sars-CoV2, Corona Virus Infection, COVID, Coronavirus
- Being tested
- Hydroxychloroquine, Vitamin C, Vitamin D, Zinc
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Plaquenil
Prophylaxis treatment for COVID-19
Vitamin CDietary supplement
Prophylaxis treatment for COVID-19
Vitamin DDietary supplement
Prophylaxis treatment for COVID-19
ZincDietary supplement
Prophylaxis treatment for COVID-19
| Study group | Role | What they receive |
|---|---|---|
| Medical Workers | Experimental | Medical workers who are exposed to COVID-19 and as such are at higher risk for infection. Receives: Drug: Hydroxychloroquine; Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin D; Dietary Supplement: Zinc |
| Placebo | Placebo comparator | Medical workers who are exposed to COVID-19 and as such are at a higher risk for infection Receives: Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin D; Dietary Supplement: Zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Tested Negative and Positive for COVID-19
Any symptoms of COVID-19 will be recorded in a daily diary. Symptoms (including fever measured in degrees Fahrenheit, dry cough, productive cough, difficulty speaking, wheezing, dry mouth, headache, chest tightness, difficulty with exertion, shortness of breath, sore throat, malaise, and diarrhea) will be rated as not present, mild, moderate, or severe.
Measured: 24 weeks
Secondary outcomes (1)
Adverse Events
To assess the presence or absence of side effects (graded 1-5)
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start22 Jun 2020
- Primary completion31 May 2022
- Study completion11 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- This study will focus on medical workers who at elevated risk of COVID-19 due to exposure to positive patients in the Emergency Department or Intensive Care Unit
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 254 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProgenaBiome
- Sponsor type
- University, hospital or other
- Collaborators
- DSCS CRO
- Responsible party
- Sponsor
- Investigators
- Sabine Hazan, MD, Principal investigator, ProgenaBiome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04335084
- Sponsor's protocol ID
- PRG-042
- Acronym
- HELPCOVID-19
- Status last verified
- Oct 2026
- First submitted
- 2 Apr 2020
- Last updated
- 4 Nov 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22766077Cortegiani 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.
PubMed 32173110Gao 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.
PubMed 32074550Gautret 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.
PubMed 32205204Zhang 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.
PubMed 32052466
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04335084
- Acronym / sponsor ID
- HELPCOVID-19 / PRG-042
- Conditions
- COVID-19, Coronavirus Infection, Sars-CoV2, Corona Virus Infection, COVID, Coronavirus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 254 participants (actual)
- Lead sponsor
- ProgenaBiomeUniversity, hospital or other
- Collaborators
- DSCS CRO
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 11 Apr 2024 (actual)
- First posted
- 6 Apr 2020 (actual)
- Results
- Posted 4 Nov 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19
Detailed description
In this study, subjects will take a regimen of hydroxychloroquine, vitamin C, vitamin D, and Zinc to test if this combination can prevent COVID-19. Treatment with hydroxychlorquine will last 1 day. Treatment with vitamin C, vitamin D, and and zinc will last 12 weeks. The study will last 12 weeks.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study will focus on medical workers who at elevated risk of COVID-19 due to exposure to positive patients in the Emergency Department or Intensive Care Unit
| Arm | Type | Receives |
|---|---|---|
| Medical Workers | Experimental | Drug: Hydroxychloroquine, Dietary Supplement: Vitamin C, Dietary Supplement: Vitamin D, Dietary Supplement: ZincMedical workers who are exposed to COVID-19 and as such are at higher risk for infection. |
| Placebo | Placebo comparator | Dietary Supplement: Vitamin C, Dietary Supplement: Vitamin D, Dietary Supplement: ZincMedical workers who are exposed to COVID-19 and as such are at a higher risk for infection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Informed consent, provided electronically via the EDC, demonstrating the subject understands the procedures required for the study and the purpose of the study
- Male or female patients 18 years of age or older that are considered to be high-risk individuals.
- 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)
Key exclusion criteria (22 listed)
- Refusal to provide informed consent
- Any previous positive test for COVID-19 by RT-PCR
- Symptomatic for COVID-19
- Diarrhea prior to the start of treatment
- Type I or II diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydroxychloroquineAlso: PlaquenilProphylaxis treatment for COVID-19 | Drug | Medical Workers |
| Vitamin CProphylaxis treatment for COVID-19 | Dietary supplement | Medical Workers, Placebo |
| Vitamin DProphylaxis treatment for COVID-19 | Dietary supplement | Medical Workers, Placebo |
| ZincProphylaxis treatment for COVID-19 | Dietary supplement | Medical Workers, Placebo |
Primary outcome
Number of Participants Who Tested Negative and Positive for COVID-19
Time frame: 24 weeks
Any symptoms of COVID-19 will be recorded in a daily diary. Symptoms (including fever measured in degrees Fahrenheit, dry cough, productive cough, difficulty speaking, wheezing, dry mouth, headache, chest tightness, difficulty with exertion, shortness of breath, sore throat, malaise, and diarrhea) will be rated as not present, mild, moderate, or severe.
1 secondary outcome
Adverse Events
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22766077Banjanac 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.
- Background: PubMed 32173110Cortegiani 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.
- Background: PubMed 32074550Gao 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.
- Background: PubMed 32205204Gautret 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.
- Background: PubMed 32052466Zhang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine Hazan, MD principal investigator
ProgenaBiome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine, Vitamin C and Vitamin D in people with COVID-19 and Coronavirus Infection, run by ProgenaBiome at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Who Tested Negative and Positive for COVID-19 (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04335084, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.