Last reviewed · How we verify
NCT04954040: AMBUCOV
Clinical Trial for the Prevention and Treatment With Hydroxychloroquine + Azithromycin of Acute Respiratory Syndrome Induced by COVID-19
Phase 2 trial testing Hydroxychloroquine Pill + Azithromycin Pill in Acute Respiratory Distress Syndrome in 132 participants. Status unknown.
1 October 2021
Quick facts
| Lead sponsor | Maimónides Biomedical Research Institute of Córdoba |
|---|---|
| Phase | Phase 2 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 132 |
| Start date | 10 February 2021 |
| Primary completion | 1 October 2021 |
| Estimated completion | 1 December 2021 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Hydroxychloroquine Pill + Azithromycin Pill — full drug profile →
- SOC
Conditions studied
- Acute Respiratory Distress Syndrome — all drugs for Acute Respiratory Distress Syndrome →
- Covid19 — all drugs for Covid19 →
Sponsor
Maimónides Biomedical Research Institute of Córdoba
Who can join
Adults 18 to 90, any sex, with Acute Respiratory Distress Syndrome or Covid19. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Hospitalization
Time frame: From randomization until patient's hospitalization happens, assessed up to 28 days. -
ICU admission
Time frame: From date of randomization until ICU admission as a result of COVID19, assessed up to 28 days. -
Death
Time frame: From randomization until death by any cause related to COVID19, assessed up to 28 days.
Sponsor's own description
Multi-centered, randomized, open label clinical trial to study the safety and effectivity of hydroxychloroquine + azithromycin to treat COVID-19 symptoms in primary care patients.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04954040
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT07326215 — A Study of the Efficacy and Safety of Extracorporeal Carbon Dioxide Removal Using PrismaLung+ · NA · recruiting
- NCT06919484 — The Physiological Effect of RCexp on Ventilation/Perfusion Distribution · recruiting
- NCT07126964 — Extended Prone Positioning for Intubated ARDS · NA · recruiting
Other Maimónides Biomedical Research Institute of Córdoba trials
Trials by the same sponsor.
- NCT06783491 — Efficacy of the Use of Neoadjuvant With/Without Hyperthermic Intraperitoneal Chemotherapy in the Treatment of Locally Ad · Phase 3 · not yet recruiting
- NCT07479303 — Vitamin D Status in Young Medical Residents · completed
- NCT07178379 — Hysteroscopy Anesthesia for Relief of Pain · NA · not yet recruiting
- NCT06712485 — Biomarkers in EV Associated With Marrow Adiposity in Anorexia · not yet recruiting
- NCT06579846 — 12-Month Efficacy of Exercise and Cytisinicline for Tobacco Abstinence · Phase 4 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04954040 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Maimónides Biomedical Research Institute of Córdoba
- Last refreshed: 7 July 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/NCT04954040.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing