This is a double-blind, multicentre, multinational study to evaluate the safety andcollect preliminary efficacy data of Codivir drug product in 130 hospitalized adults withmoderate COVID-19 symptoms. COVID-19 symptoms (fever, cough, myalgia and changes in smellor taste) onset must be within 7 days prior enrolment. Treatment will begin in thehospital, participants will be discharged according to medical decision and continue thetreatment until to Day 7 at home and followed up to day 28.
eligible hospitalized participants will be recruited to the study and will receive
standard of care treatments as well as Codivir or placebo, which will be administered at
a dose of 20 mg SC, twice a day, for 7 days. If up to medical decision of the medical
staff in the site, the patient should be released before Day 7, site study team will
contact the medical monitor of the study to get the instructions. Participants will be
followed up to the 28th day via phone contact. The phone visit will be performed to
monitor the clinical symptoms, collect adverse events and concomitant medication and
provide the patient with additional instructions, if relevant.
If they have progressed well, they will continue the treatment up to Day 7 at home,
receiving a nurse's home visit twice a day to administer Codivir and collect vital signs.
Participants will be followed up to Day 28 by telemedicine. A doctor will call them
periodically to monitor the clinical evolution, collect adverse events, concomitant
medication and instruct the participants. In case of unfavorable evolution, the
participants will remain hospitalized receiving the appropriate care. The investigator
will decide whether or not the investigational medication will continue, considering the
participant's health and well-being.
Drug: Covidir injections
administration of the investigational product CODIVIR/Placebo at a dose of 20 mg twice a
day subcutaneously at visits Day0-Day6 (7 days total)
Other Name: Experimental drug administration
Diagnostic Test: Quantitative PCR SARS-CoV-2
detection of viral RNA in nasopharyngeal and oropharyngeal samples by the Real Time
Protein Chain Reaction technique.
Diagnostic Test: IgM and IgG dosage
lood collection for dosage of Anti SARS-CoV-2 antibodies.
Diagnostic Test: Screening Blood tests
omplete blood count, urea, creatinine, uric acid, sodium, potassium, chloride, calcium,
glucose, glycated hemoglobin, alkaline phosphatase (FA), alanine aminotransferase (ALT),
aspartate aminotransferase (AST), total bilirubins and fractions ( BTF), total proteins
and fractions (PTF), lipid profile (total cholesterol, fractions and triglycerides);
coagulogram (TP, aPTT); D-dimer; C-reactive protein; HIV, HBV, HCV serology; Ferritin;
troponin, fibrinogen,Coagulogram (TP, aPTT); D-dimer, Pregnancy test for non-sterile
women.
Diagnostic Test: Electrocardiogram
valuation by the principal investigator or assistant physician with a complete physical
examination
Other Name: ECG
Other: NEWS-2 score
assessment of the participant by the NEWS-2 score.
Other: WHO score
assessment of the participant by the score of the World Health Organization.
Other: Physical examination
evaluation by the principal investigator or assistant physician
Other: COVID-19-Related Symptoms assessment
will be completed by the study staff member based on patient status and answers.
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.
Hospital de Amor
Paulo Prata, Barretos/SP/BRA, Brazil
Infection Control
Prado, Belo Horizonte/MG/BRA, Brazil
Instituto Lobus
Casa de Pedra, Volta Redonda/RJ/BRA, Brazil
A2Z Clinical
Vila Martina, Volta Redonda/RJ/BRA, Brazil
Casa de Saude
Centro, Brazil
Not Provided