Your browser doesn't support javascript.
Study of Codivir in Patients With COVID-19
ClinicalTrials.gov; 16/06/2021; TrialID: NCT04930861
Clinical Trial Register | ICTRP | ID: ictrp-NCT04930861
ABSTRACT

Condition

Covid19

Intervention

Drug Covidir injections;Diagnostic Test One Step Test;Diagnostic Test IgM and IgG dosage;Diagnostic Test RT-PCR SARS-CoV-2;Diagnostic Test Screening blood test;Diagnostic Test ECG;Diagnostic Test Medical evaluation;Diagnostic Test NEWS-2 score;Diagnostic Test WHO score

Primary 

outcome:

Incidence and severity of adverse events related to the investigational product.

Criteria


Inclusion Criteria

1. Age between 18 and 60 years;

2. Male or female;

3. SARS-CoV-2 infection indicated by rapid test and confirmed by RT-PCR.

4. Mild or moderate COVID-19

- The oxygen saturation in room air >93%;

- <30 breaths per minute;

5. No signs of hemodynamic decompensation.

6. Absence of pregnancy in women of childbearing age.

7. Able to understand and comply with the requirements of the protocol.

8. Consent to participate

Exclusion Criteria

1. Participants in need of O2 supplementation by catheter or mask, invasive mechanical
ventilation, or vasopressors.

2. Onset of symptoms or rapid test or positive RT-PCR for more than 72 hours of
inclusion.

3. Participants in use or expected to use within 24 hours prior to the inclusion of drugs
that are under clinical investigation as a therapeutic option for the treatment of
COVID-19 (eg hydroxychloroquine, chloroquine, ivermectin, nitazoxanide, among others)
during the study period;

4. Body mass index less than 19.9 or greater than 35;

5. Comorbidities such as other serious infections, active malignancies, autoimmune
diseases, liver, kidney or heart failure; another systemic disease and / or laboratory
abnormality, which, in the investigator's opinion, prevent the patient from
participating in the study;

6. Concomitant HIV, HBV or HCV infection.

7. Pregnancy or lactation;

8. Participation in another clinical trial in the 12 months preceding inclusion;

9. Anti-COVID-19 vaccination at any time;

10. Vaccination for any other infection in the 4 weeks prior to inclusion;

11. Any condition that increases the risk of participating in the study, in the opinion of
the investigator.


Collection: Clinical trial registers Database: ICTRP Topics: Vaccines Year: 2021 Document Type: Clinical Trial Register

Similar

MEDLINE

...
LILACS

LIS

Collection: Clinical trial registers Database: ICTRP Topics: Vaccines Year: 2021 Document Type: Clinical Trial Register