Terminated PHASE2 INTERVENTIONAL 4-arm NCT04363827

Protect: Study With Hydroxychloroquine for Prevention and Early Phase Treatment of Coronavirus Disease (COVID-19) (PROTECT)

PROTECT: A Randomized Study With Hydroxychloroquine Versus Observational Support for Prevention or Early Phase Treatment of Coronavirus Disease (COVID-19)

Sponsor: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

Conditions COVID19 Hydroxychloroquine Prophylaxis SARS-CoV-2 Treatment

Interventions Hydroxychloroquine

Updated 8 times since 2020 Last updated: Mar 6, 2025 Started: May 14, 2020 Primary completion: Sep 30, 2021 Completion: Sep 30, 2021

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Terminated

Difficulties in recruiting subjects were observed soon after the study was initiated. This difficulty was attributed to the decreased incidence of infections which occurred in the period following the first lock down.

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This PHASE2 trial investigates COVID19 and Hydroxychloroquine and is currently terminated or withdrawn. Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS leads this study, which shows 8 recorded versions since 2020 — indicating limited longitudinal coverage. Longitudinal tracking of infectious disease trials helps identify durability of treatment effects.

Status Flow

Change History

8 versions recorded

Apr 2025 — Present [monthly]

Terminated PHASE2

Status: Unknown → Terminated
Sep 2024 — Apr 2025 [monthly]

Unknown PHASE2
Jul 2024 — Sep 2024 [monthly]

Unknown PHASE2

Status: Unknown Status → Unknown
Mar 2023 — Jul 2024 [monthly]

Unknown Status PHASE2

Status: Active Not Recruiting → Unknown Status
Mar 2021 — Mar 2023 [monthly]

Active Not Recruiting PHASE2

Status: Recruiting → Active Not Recruiting

▶ Show 3 earlier versions

Jan 2021 — Mar 2021 [monthly]

Recruiting PHASE2
Jul 2020 — Jan 2021 [monthly]

Recruiting PHASE2

Status: Not Yet Recruiting → Recruiting
May 2020 — Jul 2020 [monthly]

Not Yet Recruiting PHASE2

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS
University of Bologna

Data source: Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Meldola, Italy