Adults 18 to 99, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Recruitment FeasibilityPrimary· Study period, up to two months from the day the first participant was screened
To evaluate the feasibility of this protocol including participants' recruitment within the estimated time frame, i.e. understand the ability of the team to identify eligible participants, enroll them, retain them and follow them up until study completion.
Group
Value
95% CI
Study Arm
46
Resource UtilizationPrimary· Study period, up to two months from the day the first participant was screened
To evaluate the utilization of tests and drug for this study in consideration with the limited availability of both for research purposes as reflected on the number of participants that got tested and received at least one dose of the drug.
Group
Value
95% CI
Study Arm - Hydroxychloroquine Sulfate (HCQ)
46
Safety as Reflected on the Number and Severity of Adverse Events and Serious Adverse EventsPrimary· 28 day post enrollment
To Determine the Safety profile for a previously well studied drug in this select group of HCP. Incidence of well described side effects would be studied over the course of the study and will be compared with the side effects and their prevalence as described in the Pharmacy manual for HCQ.
Serious Adverse events
Group
Value
95% CI
Study Arm - Hydroxychloroquine Sulfate (HCQ)
0
Adverse events
Group
Value
95% CI
Study Arm - Hydroxychloroquine Sulfate (HCQ)
24
Early Feasibility as Reflected on the Number of Participants Contracting COVID-19 (10% or Less) in Comparison to the Expected 30% as Per CDC.Primary· 28 day post enrollment
To evaluate the early efficacy of HCQ in high-risk, healthy volunteers in the prevention of acquiring COVID-19 while continuing to follow standard precautions that meet or exceed Centers of Disease Control (CDC) guidelines.
Group
Value
95% CI
Study Arm - Hydroxychloroquine Sulfate (HCQ)
0
Adverse events — posted to ClinicalTrials.gov
Time frame: Overall follow up period: 6 month.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The study proposes to conduct an open-label Phase II trial to evaluate the feasibility, safety and early efficacy of hydroxychloroquine (HCQ) administration in reduction of transmission of severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) and development of Corona Virus Disease 2019 (COVID-19) in high-risk, healthy acute care provider participants exposed, directly or indirectly, to COVID-19 patients. There is a more than 50 years track record of safety of HCQ for treatment and prevention of various disease states. Early data on use of HCQ for COVID treatment suggests anti-viral activity and immunomodulatory properties for reducing inflammation associated with COVID-19.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT03305341 — Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologic Mix
· EARLY_PHASE1
· active not recruiting
NCT06482138 — Dysfunction of Olfaction After COVID-19 Infection: Morphological and Histomolecular Investigation
· NA
· recruiting
NCT04924803 — Community Developed Technology-Based Messaging to Increase COVID-19 Vaccine Uptake Among People Who Inject Drugs
· NA
· active not recruiting
NCT05013632 — COVID-19 International Drug Pregnancy Registry
· recruiting
NCT04806061 — Urine Alkalinisation in COVID-19
· NA
· active not recruiting
NCT06987708 — Evaluating the Impact of a 12-month Multi-Modal Lifestyle Management Intervention on Disease Relevant Biomarkers
· NA
· not yet recruiting
NCT06575894 — Implementing Mental Health Programs Across Communities in Iowa & Indiana for Transformation
· NA
· not yet recruiting
NCT07442669 — Utilization of Lung Ultrasound Score in Decision for Minimally Invasive Surfactant Administration
· NA
· not yet recruiting
NCT06991166 — OBWELL: Innovative Psychotherapeutic Intervention to Treat Postpartum Depression
· NA
· recruiting
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 Hackensack Meridian Health
Last refreshed: 12 May 2021
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/NCT04345653.