Who is sponsoring NCT04486508?

NCT04486508 is sponsored by Rajaie Cardiovascular Medical and Research Center.

What drugs are being tested in NCT04486508?

Interventions in NCT04486508: intermediate dose Enoxaparin/ unfractionated heparin, standard prophylactic dose Enoxaparin/ unfractionated heparin, Atorvastatin 20mg, Matched placebo.

Is NCT04486508 still recruiting?

NCT04486508 is currently completed. Last updated 17 August 2021.

Last reviewed 2021-08-17 · How we verify

NCT04486508: INSPIRATION

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

Intermediate-dose vs Standard Prophylactic Anticoagulation and Statin vs Placebo in ICU Patients With COVID-19

Completed Phase 3 Last updated 17 August 2021

What this trial tests

Phase 3 trial testing intermediate dose Enoxaparin/ unfractionated heparin in Covid19 in 600 participants. Completed in 5 July 2021.

Timeline

30 July 2020

Primary endpoint
4 April 2021

5 July 2021

Quick facts

Lead sponsor	Rajaie Cardiovascular Medical and Research Center
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	600
Start date	30 July 2020
Primary completion	4 April 2021
Estimated completion	5 July 2021
Sites	1 location across Iran

Drugs / interventions tested

intermediate dose Enoxaparin/ unfractionated heparin — full drug profile →
standard prophylactic dose Enoxaparin/ unfractionated heparin — full drug profile →
Atorvastatin 20mg — full drug profile →
Matched placebo — full drug profile →

Conditions studied

Covid19 — all drugs for Covid19 →

Sponsor

Rajaie Cardiovascular Medical and Research Center — full company profile →

Who can join

18 and older, any sex, with Covid19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In a 2x2 factorial design randomized controlled trial, the investigators aim to elaborate the safety and efficacy of two pharmacological regimens on outcomes of critically-ill patients with COVID-19. The first randomization entails open-label assignment to intermediate versus standard dose prophylactic anticoagulation. The investigators hypothesize that intermediate dose compared with standard prophylactic dose anticoagulation will have a superior efficacy with respect to a composite of venous thromboembolism (VTE), requirement for extracorporeal membrane oxygenation (ECMO), or all-cause mortality. The second randomization will be double-blind assignment of the included patients to atorvastatin 20mg daily versus matching placebo. The hypothesis is that statin therapy, compared with placebo, will reduce the composite of VTE, need for ECMO, or all-cause mortality.

Publications & conference data

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

Effect of Intermediate-Dose vs Standard-Dose Prophylactic Anticoagulation on Thrombotic Events, Extracorporeal Membrane Oxygenation Treatment, or Mortality Among Patients With COVID-19 Admitted to the Intensive Care Unit: The INSPIRATION Randomized Clinical Trial.
INSPIRATION Investigators, Sadeghipour P, Talasaz AH, Rashidi F, et al · · 2021 · cited 491× · PMID 33734299 · DOI 10.1001/jama.2021.4152
Long COVID: post-acute sequelae of COVID-19 with a cardiovascular focus.
Raman B, Bluemke DA, Lüscher TF, Neubauer S. · · 2022 · cited 444× · PMID 35176758 · DOI 10.1093/eurheartj/ehac031
COVID-19-associated coagulopathy and antithrombotic agents-lessons after 1 year.
Leentjens J, van Haaps TF, Wessels PF, Schutgens REG, et al · · 2021 · cited 161× · PMID 33930350 · DOI 10.1016/s2352-3026(21)00105-8
COVID-19 and thrombosis: From bench to bedside.
Ali MAM, Spinler SA. · · 2021 · cited 140× · PMID 33338635 · DOI 10.1016/j.tcm.2020.12.004
Association between antecedent statin use and decreased mortality in hospitalized patients with COVID-19.
Gupta A, Madhavan MV, Poterucha TJ, DeFilippis EM, et al · · 2021 · cited 132× · PMID 33637713 · DOI 10.1038/s41467-021-21553-1
Cytokine release syndrome in COVID-19: a major mechanism of morbidity and mortality.
Que Y, Hu C, Wan K, Hu P, et al · · 2022 · cited 120× · PMID 33616462 · DOI 10.1080/08830185.2021.1884248
Cardiac involvement in the long-term implications of COVID-19.
Satterfield BA, Bhatt DL, Gersh BJ. · · 2022 · cited 101× · PMID 34686843 · DOI 10.1038/s41569-021-00631-3
Venous Thromboembolism in Hospitalized Critical and Noncritical COVID-19 Patients: A Systematic Review and Meta-analysis.
Mansory EM, Srigunapalan S, Lazo-Langner A. · · 2021 · cited 80× · PMID 34240001 · DOI 10.1055/s-0041-1730967

Verify or expand the search:

Other recruiting trials for Covid19

Currently open trials in the same condition.

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

Other Rajaie Cardiovascular Medical and Research Center trials

Trials by the same sponsor.

NCT06541691 — Coated or Chewable Aspirin and a Hybrid Strategy to Mitigate Adverse Effects of Air Pollution in Stable Atherosclerotic · NA · recruiting
NCT06124937 — Empagliflozin to Prevent Post-Operative Atrial Fibrillation · Phase 3 · unknown
NCT05705089 — Rivaroxaban vErsus Warfarin for Antithrombotic TheRapy in Patients With LeFt Ventricular Thrombus After Acute STEMI · Phase 3 · completed
NCT04304118 — Rajaie Cardiomyopathy and Myocarditis Registry · unknown
NCT03926156 — RIvoraxaban in Mitral Stenosis · Phase 3 · terminated

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 NCT04486508 (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 Rajaie Cardiovascular Medical and Research Center
Last refreshed: 17 August 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/NCT04486508.

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