NCT04335084 (HELPCOVID-19) is a Phase 2 clinical trial of Hydroxychloroquine in COVID-19, sponsored by ProgenaBiome.

Who is sponsoring NCT04335084?

NCT04335084 is sponsored by ProgenaBiome.

What drugs are being tested in NCT04335084?

Interventions in NCT04335084: Hydroxychloroquine, Vitamin C, Vitamin D, Zinc.

What condition does NCT04335084 study?

NCT04335084 studies COVID-19, Coronavirus Infection, Sars-CoV2, Corona Virus Infection, COVID, Coronavirus, Coronavirus-19, Coronavirus 19.

Is NCT04335084 still recruiting?

NCT04335084 is currently completed. Last updated 5 June 2025.

Last reviewed 2025-06-05 · How we verify

NCT04335084: HELPCOVID-19

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Infection

Completed Phase 2 Last updated 5 June 2025

What this trial tests

Phase 2 trial testing Hydroxychloroquine in COVID-19 in 254 participants. Completed in 11 April 2024.

Timeline

22 June 2020

Primary endpoint
31 May 2022

11 April 2024

Quick facts

Lead sponsor	ProgenaBiome
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	single group
Masking	double
Primary purpose	prevention
Enrollment	254
Start date	22 June 2020
Primary completion	31 May 2022
Estimated completion	11 April 2024
Sites	1 location across United States

Drugs / interventions tested

Hydroxychloroquine (HYDROXYCHLOROQUINE) — full drug profile →
Vitamin C — full drug profile →
Vitamin D
Zinc — full drug profile →

Conditions studied

COVID-19 — all drugs for COVID-19 →
Coronavirus Infection — all drugs for Coronavirus Infection →
Sars-CoV2 — all drugs for Sars-CoV2 →
Corona Virus Infection — all drugs for Corona Virus Infection →

Sponsor

ProgenaBiome — full company profile →

Who can join

18 and older, any sex, with COVID-19 or Coronavirus Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

The COVID-19 pandemic and physical activity.
Woods JA, Hutchinson NT, Powers SK, Roberts WO, et al · · 2020 · cited 287× · PMID 34189484 · DOI 10.1016/j.smhs.2020.05.006
Immune-boosting role of vitamins D, C, E, zinc, selenium and omega-3 fatty acids: Could they help against COVID-19?
Shakoor H, Feehan J, Al Dhaheri AS, Ali HI, et al · · 2021 · cited 206× · PMID 33308613 · DOI 10.1016/j.maturitas.2020.08.003
Endothelial dysfunction in COVID-19: Current findings and therapeutic implications.
Nägele MP, Haubner B, Tanner FC, Ruschitzka F, et al · · 2020 · cited 205× · PMID 33161318 · DOI 10.1016/j.atherosclerosis.2020.10.014
COVID-19: Characteristics and Therapeutics.
Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206
Chloroquine or hydroxychloroquine for prevention and treatment of COVID-19.
Singh B, Ryan H, Kredo T, Chaplin M, et al · · 2021 · cited 140× · PMID 33624299 · DOI 10.1002/14651858.cd013587.pub2
Flattening the COVID-19 Curve With Natural Killer Cell Based Immunotherapies.
Market M, Angka L, Martel AB, Bastin D, et al · · 2020 · cited 115× · PMID 32655581 · DOI 10.3389/fimmu.2020.01512
Vitamin D receptor stimulation to reduce acute respiratory distress syndrome (ARDS) in patients with coronavirus SARS-CoV-2 infections: Revised Ms SBMB 2020_166.
Quesada-Gomez JM, Entrenas-Castillo M, Bouillon R. · · 2020 · cited 113× · PMID 32535032 · DOI 10.1016/j.jsbmb.2020.105719
The importance of vitamin d metabolism as a potential prophylactic, immunoregulatory and neuroprotective treatment for COVID-19.
Xu Y, Baylink DJ, Chen CS, Reeves ME, et al · · 2020 · cited 100× · PMID 32847594 · DOI 10.1186/s12967-020-02488-5

Verify or expand the search:

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Other recruiting trials for COVID-19

Currently open trials in the same condition.

NCT07183709 — Safety and Immunogenicity Trial of PepGNP-COVID19 Vaccine in Adults · Phase 1 · active not recruiting
NCT07300839 — A Study to Learn About a COVID-19 Vaccine in Healthy Adults 50 Through 64 Years of Age · Phase 3 · active not recruiting
NCT07221162 — A Safety and Immunogenicity Trial of Boost-2867 Vaccine, Via Intranasal and Intramuscular Routes · Phase 1 · recruiting
NCT07215520 — Safety and Tolerability of a Newcastle Disease Virus-Based Mucosal COVID-19 Vaccine in Previously Vaccinated Adults · Phase 2 · recruiting
NCT07222384 — A Study to Learn About BNT162b2 (LP.8.1)-Adapted Vaccine Against SARS-CoV-2 in Children 5 Through 11 Years of Age That A · Phase 3 · active not recruiting

Other ProgenaBiome trials

Trials by the same sponsor.

NCT04949230 — A Retrospective Study of COVID-19 Treatments · completed
NCT04482686 — Trial of Combination Therapy to Treat COVID-19 Infection · Phase 1 · completed
NCT04334512 — A Study of Quintuple Therapy to Treat COVID-19 Infection · Phase 2 · completed
NCT04359836 — A Study to Explore the Role of Gut Flora in COVID-19 Infection · recruiting
NCT04031469 — A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Disease · suspended

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT04335084 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by ProgenaBiome
Last refreshed: 5 June 2025

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04335084.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing