NCT04355247

Prophylactic Corticosteroid to Prevent COVID-19 Cytokine Storm

Status unknown Phase 2 Last updated 21 April 2020

What this trial tests

Phase 2 trial testing MethylPREDNISolone 80 Mg/mL Injectable Suspension in Covid-19 in 20 participants. Status unknown.

Timeline

14 April 2020

Primary endpoint
31 July 2020

30 April 2021

Quick facts

Lead sponsor	Auxilio Mutuo Cancer Center
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	prevention
Enrollment	20
Start date	14 April 2020
Primary completion	31 July 2020
Estimated completion	30 April 2021
Sites	2 locations across Puerto Rico

Drugs / interventions tested

• MethylPREDNISolone 80 Mg/mL Injectable Suspension — full drug profile →

Conditions studied

• Covid-19 — all drugs for Covid-19 →

Sponsor

Auxilio Mutuo Cancer Center — full company profile →

Who can join

18 and older, any sex, with Covid-19. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a Phase II pilot exploratory study designed to investigate if prophylactic treatment with short term steroids administered to high risk Covid-19 patient might prevent cytokine storm and progression to respiratory failure. High risk is defined based on serologic markers of inflammation that include abnormalities of Interleukin 6 (IL-6), Ferritin , D-dimer, Lactate Dehydrogenase (LDH), as well as lymphopenia and impaired O2 saturation prior to or on the 7th day of first symptom of Covid-19.

Publications & conference data

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

1. Cytokine storm and leukocyte changes in mild versus severe SARS-CoV-2 infection: Review of 3939 COVID-19 patients in China and emerging pathogenesis and therapy concepts.
   Wang J, Jiang M, Chen X, Montaner LJ. · · 2020 · cited 551× · PMID 32534467 · DOI 10.1002/jlb.3covr0520-272r
2. COVID-19: Characteristics and Therapeutics.
   Chilamakuri R, Agarwal S. · · 2021 · cited 192× · PMID 33494237 · DOI 10.3390/cells10020206
3. A review of potential suggested drugs for coronavirus disease (COVID-19) treatment.
   Tarighi P, Eftekhari S, Chizari M, Sabernavaei M, et al · · 2021 · cited 80× · PMID 33482181 · DOI 10.1016/j.ejphar.2021.173890
4. The mechanism underlying extrapulmonary complications of the coronavirus disease 2019 and its therapeutic implication.
   Ning Q, Wu D, Wang X, Xi D, et al · · 2022 · cited 64× · PMID 35197452 · DOI 10.1038/s41392-022-00907-1
5. A critical evaluation of glucocorticoids in the management of severe COVID-19.
   Solinas C, Perra L, Aiello M, Migliori E, et al · · 2020 · cited 61× · PMID 32616381 · DOI 10.1016/j.cytogfr.2020.06.012
6. Vasculopathy and Coagulopathy Associated with SARS-CoV-2 Infection.
   Labò N, Ohnuki H, Tosato G. · · 2020 · cited 57× · PMID 32629875 · DOI 10.3390/cells9071583
7. Corticosteroids for COVID-19 Therapy: Potential Implications on Tuberculosis.
   Gopalaswamy R, Subbian S. · · 2021 · cited 52× · PMID 33917321 · DOI 10.3390/ijms22073773
8. An updated overview of recent advances, challenges, and clinical considerations of IL-6 signaling blockade in severe coronavirus disease 2019 (COVID-19).
   Elahi R, Karami P, Heidary AH, Esmaeilzadeh A. · · 2022 · cited 33× · PMID 35074571 · DOI 10.1016/j.intimp.2022.108536