Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID)
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|ClinicalTrials.gov Identifier: NCT04451174|
Recruitment Status : Terminated (Corticosteroid use approval)
First Posted : June 30, 2020
Last Update Posted : June 3, 2021
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Drug: Prednisone||Phase 3|
We are in the middle of a coronavirus pandemic, facing a large number of infections in serious cases and an increasing number of deaths in Chile. As of June 11, 2020, there are 154092 cases confirmed by COVID - 19 i and 2648 deaths in our country.
Most patients have mild disease, but older people and those with comorbidities can develop severe disease that requires hospitalization, some form of ventilatory support, and eventually intensive care unit admission. The pathophysiology occurs in two different overlapping phases, the initial pathogen with viral replication, followed by the host's inflammatory response with varying degrees of severity associated with different clinical characteristics. The pathological progression in some cases of severe COVID-19 would be explained by an excess of proinflammatory cytokines, which leads to diffuse alveolar damage, with the development of acute respiratory distress syndrome (ARDS) and inflammatory compromise of multiple systems until death.
In the absence of any proven antiviral therapy, current clinical treatment is primarily supportive care, supplemental oxygen, and mechanical ventilatory support.
Clinical trials have been published and called to demonstrate the usefulness of therapies in the context of this pandemic.
The role of corticosteroids is not fully defined. Observational studies report better results in decreasing disease progression in those COVID-19 patients who received corticosteroids early.
We hypothesize in this study that treatment in mild disease (defined as that requiring supplemental oxygen, but without the need for ventilatory support) can attenuate the host's excessive respiratory and systemic inflammatory responses.
The objective of this study is to evaluate the effect of early treatment with prednisone to decrease the progression of the disease.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Early Use of Corticosteroids in Non-critical Patients With COVID-19 Pneumonia (PREDCOVID)|
|Actual Study Start Date :||June 23, 2020|
|Actual Primary Completion Date :||January 30, 2021|
|Actual Study Completion Date :||January 30, 2021|
Prednisone 40 mg days 1 to 4. Then Prednisone 20 mg days 5 to 8.
Prednisone 40 mg days 1 to 4. Then, prednisone 20 mg days 5 to 8.
|No Intervention: Control|
- Composite Primary End-point: Admission to ICU, Need for Invasive Mechanical Ventilation or All-cause Death by Day 28 [ Time Frame: 28 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): NCT04451174
|Hospital Santiago Oriente|
|Santiago, Peñalolen, Chile, 7930124|
|Principal Investigator:||Mauricio Salinas, MD||University of Chile|