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To Study Clinical Characteristics, Treatment Outcome of Coronavirus (COVID-19) Patients
CTRI; 20-05-2020; TrialID: CTRI/2020/05/025247
Clinical Trial Register | ICTRP | ID: ictrp-CTRI202005025247
ABSTRACT

Condition

Health Condition 1 B972- Coronavirus as the cause of diseases classified elsewhere

Primary 

outcome:

A. Clinical status of subject

1. 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 older



2. 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

Coleções: Registros de ensaios clínicos Base de dados: ICTRP Ano de publicação: 2020 Tipo de documento: Clinical Trial Register

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Coleções: Registros de ensaios clínicos Base de dados: ICTRP Ano de publicação: 2020 Tipo de documento: Clinical Trial Register