1.
ClinicalTrials.gov; 19/01/2022; TrialID: NCT05218356
Clinical Trial Register
| ICTRP | ID: ictrp-NCT05218356
ABSTRACT
Condition:
COVID-19Intervention:
Drug: Covidir injections;Diagnostic Test: Quantitative PCR SARS-CoV-2;Diagnostic Test: IgM and IgG dosage;Diagnostic Test: Screening Blood tests;Diagnostic Test: Electrocardiogram;Other: NEWS-2 score;Other: WHO score;Other: Physical examination;Other: COVID-19-Related Symptoms assessmentPrimary outcome:
Change in World Health Organization Ordinal Scale for clinical improvementCriteria:
Inclusion Criteria:
- Age between 18 and 75 years
- Male or female
- SARS-CoV-2 infection indicated by confirmed RT-PCR test
- Moderate hospitalized COVID-19 (at least two out of three criterias below):
- Evidence of lower respiratory disease during clinical assessment (cough, fever,
difficulty breathing) or imaging (X-rays)
- Oxygen saturation (SpO2) in room air < 93%
- <30 breaths per minute
- No signs of hemodynamic decompensation
- Absence of pregnancy in women of childbearing age
- Ability to understand and comply with the requirements of the protocol
- Consent to participate
- Consent to use at least one highly effective contraception methods (condoms, IUD, oral
contraceptives) since the ICF signature and at least 30 days after the study.
Exclusion Criteria:
- Patients receiving oxygen supplementation except of nasal prongs, nasal intermittent
positive pressure ventilation (NIPPV) or high flow nasal cannula (HFNC) that are
allowed to be enrolled to the study).
- Positive RT-PCR test more than 72 hours prior to enrolment.
- Onset of symptoms more than 7 days prior to enrolment.
- Participant using drugs that are under clinical investigation in last 30 days.
- Body mass index less than 19.9 or greater than 35.
- 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.
- Concomitant HIV, HBV or HCV infection.
- Pregnancy or lactation.
- Vaccination for any other infection in the 4 weeks prior to enrolment.
- Any condition that increases the risk of participating in the study, in the opinion of
the investigator.
2.
ClinicalTrials.gov; 16/06/2021; TrialID: NCT04930861
Clinical Trial Register
| ICTRP | ID: ictrp-NCT04930861
ABSTRACT
Condition:
Covid19Intervention:
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 scorePrimary 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.