Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection (CORTI-Covid)
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|ClinicalTrials.gov Identifier: NCT04344288|
Recruitment Status : Terminated (Competent Authority's decision)
First Posted : April 14, 2020
Last Update Posted : October 26, 2020
Infection with the SARS-Cov-2 virus, responsible of severe acute respiratory distress syndrome (SARS), is an emerging infectious disease called Covid-19 and declared as pandemic by the World Health Organization on March 11, 2020. This pandemic is responsible of significant mortality. In France, several thousand patients are hospitalized in intensive care units, and their number continues to increase. Mortality during Covid-19 is mainly linked to acute respiratory distress syndrome, which frequency is estimated in France to occur in 6% of infected patients. Comorbidities such as cardiovascular conditions, obesity and diabetes increase susceptibility to severe forms of Covid-19 and associated mortality. Therapeutic management has three components: symptomatic management, including supplementary oxygen therapy and in case of respiratory distress mechanical ventilation; the antiviral approach; and immunomodulation, aiming at reducing inflammation associated with viral infection, which is considered to take part in severe presentations of the disease.
During Covid-19 viral pneumonia related to SARS-COv-2, there is a significant release of pro-inflammatory cytokines in the acute phase of viral infection, which could participate in viral pneumonia lesions. In children with less mature immune system than adults, SARS-Cov-2 infection is less severe. The current prevailing assumption is that severe forms of Covid-19 may not only be related to high viral replication, but also to an excessive inflammatory response favoring acute lung injury and stimulating infection.
The investigators hypothesize that early control of the excessive inflammatory response may help reducing the risk of acute respiratory distress syndrome.
The investigators will evaluate the benefit, safety and tolerability of corticosteroid therapy to reduce the rate of subjects hospitalized for Covid-19 viral pneumonia who experience clinical worsening with a need of high-flow supplemental oxygen supplementation or transfer in intensive care units for respiratory support.
|Condition or disease||Intervention/treatment||Phase|
|Viral Pneumonia Human Coronavirus COVID-19||Drug: Prednisone Other: Control group||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||11 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Corticosteroids During Covid-19 Viral Pneumonia Related to SARS-Cov-2 Infection|
|Actual Study Start Date :||April 21, 2020|
|Actual Primary Completion Date :||August 18, 2020|
|Actual Study Completion Date :||August 18, 2020|
Experimental: Prednisone group
Prednisone during 10 days after randomization
The experimental group will receive oral prednisone during 10 days (0.75 mg/kg/day during 5 days then 20 mg/day during 5 more days)
Other: Control group
The control group will receive standard of care according to the international recommendations and practices of the investigational site. No corticosteroid therapy can be prescribed in this group.
- Number of patients with a theoretical respiratory indication for transfer to intensive care unit evaluated by a SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. [ Time Frame: 7 days ]SpO2 <90% stabilized at rest and under not more than 5 L / min of supplemental oxygen using medium concentration mask. measured twice at 5-15 min intervalsThe average value of the two measurements will be calculated.
- disease severity assessed on a 7-level ordinal scale [ Time Frame: 7 days ]level1: not hospitalized no limited activities, level 7: death
- number of patients with a supplemental oxygen use [ Time Frame: 7 days ]
- radiological signs on chest imaging [ Time Frame: 7 days ]Reduction of radiological signs on chest imaging
- number of patients transferred to intensive care unit [ Time Frame: 21 days ]
- number of patients requiring invasive ventilation [ Time Frame: 21 days ]
- Duration of oxygen therapy [ Time Frame: 21 days ]duration on days
- number of adverse events induced by corticosteroid treatment [ Time Frame: 21 days ]
- number of patients with infections other than SARS-CoV-2 [ Time Frame: 21 days ]
- number of deaths [ Time Frame: 21 days ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344288
|Hôpital Pneumologique et Cardiovasculaire Louis Pradel|
|Groupement Hospitalier Nord|
|Hôpital Edouard Herriot|
|Hôpital St Joseph Saint Luc|
|Hôpital St Joseph|
|Centre hospitalier Lyon Sud|
|CHU St Etienne|
|Clinique des Portes du Sud|
|Principal Investigator:||Jean-François MORNEX||Hospices Civils de Lyon|