NCT04438980: CORTIVID

Glucocorticoids in COVID-19 (CORTIVID)

Completed Phase 3 Last updated 17 May 2021

What this trial tests

Phase 3 trial testing Methylprednisolone in Covid-19 Pneumonia in 72 participants. Completed in 9 April 2021.

Timeline

15 May 2020

Primary endpoint
12 March 2021

9 April 2021

Quick facts

Lead sponsor	Fundacion Miguel Servet
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	72
Start date	15 May 2020
Primary completion	12 March 2021
Estimated completion	9 April 2021
Sites	2 locations across Spain

Drugs / interventions tested

• Methylprednisolone (methylprednisolone) — full drug profile →
• Placebo

Conditions studied

• Covid-19 Pneumonia — all drugs for Covid-19 Pneumonia →

Sponsor

Fundacion Miguel Servet

Who can join

Adults 18 to 75, any sex, with Covid-19 Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Around 30% of admitted patients with COVID-19 pneumonia develop a hyper-inflammatory state whose progression to an acute respiratory distress syndrome (ARSD) could be prevented by the early initiation of immune-modulatory agents. The role of glucocorticoids (GC) in this setting remains controversial. This study aims to assess the safety and effectiveness of GC pulses to improve the clinical outcomes of patients with COVID-19 pneumonia with risen inflammatory biomarkers.

Publications & conference data

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

1. COVID-19: Characteristics and Therapeutics.
   Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206
2. An update on drugs with therapeutic potential for SARS-CoV-2 (COVID-19) treatment.
   Drożdżal S, Rosik J, Lechowicz K, Machaj F, et al · · 2021 · cited 186× · PMID 34991982 · DOI 10.1016/j.drup.2021.100794
3. Systemic corticosteroids for the treatment of COVID-19.
   Wagner C, Griesel M, Mikolajewska A, Mueller A, et al · · 2021 · cited 151× · PMID 34396514 · DOI 10.1002/14651858.cd014963
4. Systemic corticosteroids for the treatment of COVID-19: Equity-related analyses and update on evidence.
   Wagner C, Griesel M, Mikolajewska A, Metzendorf MI, et al · · 2022 · cited 44× · PMID 36385229 · DOI 10.1002/14651858.cd014963.pub2
5. Pharmacological Modulators of Autophagy as a Potential Strategy for the Treatment of COVID-19.
   Pereira GJDS, Leão AHFF, Erustes AG, Morais IBM, et al · · 2021 · cited 36× · PMID 33920748 · DOI 10.3390/ijms22084067
6. Therapeutic role of corticosteroids in COVID-19: a systematic review of registered clinical trials.
   Raju R, V P, Biatris PS, J SJUC. · · 2021 · cited 32× · PMID 33754123 · DOI 10.1186/s43094-021-00217-3
7. Stroke in SARS-CoV-2 Infection: A Pictorial Overview of the Pathoetiology.
   Aghayari Sheikh Neshin S, Shahjouei S, Koza E, Friedenberg I, et al · · 2021 · cited 18× · PMID 33855053 · DOI 10.3389/fcvm.2021.649922
8. Mast cells: Therapeutic targets for COVID-19 and beyond.
   Lam HY, Tergaonkar V, Kumar AP, Ahn KS. · · 2021 · cited 17× · PMID 34467628 · DOI 10.1002/iub.2552