1.
CTRI; 20-05-2020; TrialID: CTRI/2020/05/025247
Clinical Trial Register
| ICTRP | ID: ictrp-CTRI202005025247
RESUMO
Condition:
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewherePrimary outcome:
A. Clinical status of subject1. Hospitalized, not requiring supplemental oxygen;
2. Hospitalized, requiring supplemental oxygen;
3. Hospitalized, on non-invasive ventilation or high flow oxygen devices;
4. Hospitalized, on invasive mechanical ventilation or ECMO;
B. Clinical status of subject at discharge
1. Hospitalized, not requiring supplemental oxygen;
2. Hospitalized, requiring supplemental oxygen;
3. Death;
Timepoint: During Hospitalization Baseline to till Discharge
Criteria:
Inclusion criteria: 1. 18 years or older2. All suspected COVID-19 hospitalized patient
3. Willing and able to provide written informed
consent prior to performing study procedures
4. Has laboratory-non confirmed SARS-CoV-2
infection as determined by PCR or other
commercial or public health assay but with
typical signs including fever, cough, loss
of test, sense of smell and headache etc.
5. Illness of any duration, and at least one of
the following: Radiographic infiltrates by
imaging (chest x-ray, CT scan, etc.), or
Clinical assessment (evidence of
rales/crackles on exam) AND SpO2 <= 94% on
room air, or require mechanical ventilation
and/or supplemental oxygen.
Exclusion criteria: 1. Participation in any other clinical trial of
an experimental treatment for COVID-19
2. Immunocompromised patients taking medication
upon screening
3. Consideration by the investigator, for any
reason, that the subject is an unsuitable
candidate to receive study treatment