NCT04351516: COVID65plus

Test and Treat COVID 65plus+

Withdrawn Phase 2, PHASE3 Last updated 15 January 2021

What this trial tests

Phase 2, PHASE3 trial testing Hydroxychloroquine in SARS-CoV 2. Withdrawn.

Timeline

21 April 2020

Primary endpoint
31 December 2020

1 May 2021

Quick facts

Lead sponsor	University Hospital Tuebingen
Phase	Phase 2, PHASE3
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Start date	21 April 2020
Primary completion	31 December 2020
Estimated completion	1 May 2021
Sites	2 locations across Germany

Drugs / interventions tested

• Hydroxychloroquine (HYDROXYCHLOROQUINE) — full drug profile →
• Placebo

Conditions studied

• SARS-CoV 2 — all drugs for SARS-CoV 2 →
• COVID-19 — all drugs for COVID-19 →

Sponsor

University Hospital Tuebingen

Who can join

65 and older, any sex, with SARS-CoV 2 or COVID-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Patients over equal or older than 65 yearswill be treated with a hydroxychloroquine versus placebo reduced loading dose of 600mg on the first day followed with 400mg/day divided in 2x200mg for 6 more days resulting in a total duration of therapy of 7 days. Measurement of Hydroxychloroquine-levels will be performed on day 7, . A follow-up by video or telephone conference will be performed to observe drug intake and collect adverse events during treatment phase on a daily base on working days and once during the weekend (i.e. 6 out of 7 days). After treatment phase follow-up by telephone calls will be done on day 10, 30, 60 (+/- 2 days).

Publications & conference data

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

1. Cancer, immune suppression and Coronavirus Disease-19 (COVID-19): Need to manage drug safety (French Society for Oncology Pharmacy [SFPO] guidelines).
   Slimano F, Baudouin A, Zerbit J, Toulemonde-Deldicque A, et al · · 2020 · cited 29× · PMID 32623296 · DOI 10.1016/j.ctrv.2020.102063
2. Hydroxychloroquine and Covid-19: A Cellular and Molecular Biology Based Update.
   Pal A, Pawar A, Goswami K, Sharma P, et al · · 2020 · cited 20× · PMID 32641874 · DOI 10.1007/s12291-020-00900-x
3. Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review.
   Mathioudakis AG, Fally M, Hashad R, Kouta A, et al · · 2020 · cited 14× · PMID 33333777 · DOI 10.3390/life10120350
4. Clinical trial research on COVID-19 in Germany - a systematic analysis.
   Hirt J, Rasadurai A, Briel M, Düblin P, et al · · 2021 · cited 5× · PMID 38144171 · DOI 10.12688/f1000research.55541.1
5. Test and treat COVID 65 plus - Hydroxychloroquine versus placebo in early ambulatory diagnosis and treatment of older patients with COVID19: A structured summary of a study protocol for a randomised controlled trial.
   Göpel S, Bethge W, Martus P, Kreth F, et al · · 2020 · cited 4× · PMID 32650818 · DOI 10.1186/s13063-020-04556-z