Phase 1 Clinical Study of Codivir in Outpatients With COVID-19
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Incidence and severity of adverse events related to the investigational product.
研究概览
简要总结
This is an open-label study to evaluate the safety and preliminary efficacy of Codivir in 12 mild or moderate COVID-19 patients and onset of symptoms within 72h prior to their inclusion. Treatment will begin in the hospital, participants will be discharged at Day 4 and continue the treatment up to Day 10 at home and followed up to day 28.
详细描述
Eligible participants who agree to participate will be submitted to safety assessments, an RT-PCR and a quick test for COVID-19. Everyone will receive the treatments indicated for their case, except for other investigational medications. Codivir will be administered in addition to these treatments at a dose of 20 mg SC twice daily for 10 days. Participants will remain hospitalized for the first 3 days.
If they have progressed well, they will continue the treatment up to Day 10 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 60 years;
- •Male or female;
- •SARS-CoV-2 infection indicated by rapid test and confirmed by RT-PCR.
- •Mild or moderate COVID-19:
- •The oxygen saturation in room air >93%;
- •<30 breaths per minute;
- •No signs of hemodynamic decompensation.
- •Absence of pregnancy in women of childbearing age.
- •Able to understand and comply with the requirements of the protocol.
- •Consent to participate
排除标准
- •Participants in need of O2 supplementation by catheter or mask, invasive mechanical ventilation, or vasopressors.
- •Onset of symptoms or rapid test or positive RT-PCR for more than 72 hours of inclusion.
- •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;
- •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;
- •Participation in another clinical trial in the 12 months preceding inclusion;
- •Anti-COVID-19 vaccination at any time;
- •Vaccination for any other infection in the 4 weeks prior to inclusion;
- •Any condition that increases the risk of participating in the study, in the opinion of the investigator.
研究组 & 干预措施
Covidir
Patient (adults aged ≥18 years) with mild or moderate COVID-19 and flu-symptoms onset within 72 hours prior to inclusion. Treatment begins at the hospital. On the 4th day, participants who are well will be discharged and continue treatment up to Day 10 at home. All participants will receive Codivir 20 mg SC 2 x daily.
干预措施: Covidir injections (Drug)
Covidir
Patient (adults aged ≥18 years) with mild or moderate COVID-19 and flu-symptoms onset within 72 hours prior to inclusion. Treatment begins at the hospital. On the 4th day, participants who are well will be discharged and continue treatment up to Day 10 at home. All participants will receive Codivir 20 mg SC 2 x daily.
干预措施: One Step Test (Diagnostic Test)
Covidir
Patient (adults aged ≥18 years) with mild or moderate COVID-19 and flu-symptoms onset within 72 hours prior to inclusion. Treatment begins at the hospital. On the 4th day, participants who are well will be discharged and continue treatment up to Day 10 at home. All participants will receive Codivir 20 mg SC 2 x daily.
干预措施: IgM and IgG dosage (Diagnostic Test)
Covidir
Patient (adults aged ≥18 years) with mild or moderate COVID-19 and flu-symptoms onset within 72 hours prior to inclusion. Treatment begins at the hospital. On the 4th day, participants who are well will be discharged and continue treatment up to Day 10 at home. All participants will receive Codivir 20 mg SC 2 x daily.
干预措施: RT-PCR SARS-CoV-2 (Diagnostic Test)
Covidir
Patient (adults aged ≥18 years) with mild or moderate COVID-19 and flu-symptoms onset within 72 hours prior to inclusion. Treatment begins at the hospital. On the 4th day, participants who are well will be discharged and continue treatment up to Day 10 at home. All participants will receive Codivir 20 mg SC 2 x daily.
干预措施: Screening blood test (Diagnostic Test)
Covidir
Patient (adults aged ≥18 years) with mild or moderate COVID-19 and flu-symptoms onset within 72 hours prior to inclusion. Treatment begins at the hospital. On the 4th day, participants who are well will be discharged and continue treatment up to Day 10 at home. All participants will receive Codivir 20 mg SC 2 x daily.
干预措施: ECG (Diagnostic Test)
Covidir
Patient (adults aged ≥18 years) with mild or moderate COVID-19 and flu-symptoms onset within 72 hours prior to inclusion. Treatment begins at the hospital. On the 4th day, participants who are well will be discharged and continue treatment up to Day 10 at home. All participants will receive Codivir 20 mg SC 2 x daily.
干预措施: Medical evaluation (Diagnostic Test)
Covidir
Patient (adults aged ≥18 years) with mild or moderate COVID-19 and flu-symptoms onset within 72 hours prior to inclusion. Treatment begins at the hospital. On the 4th day, participants who are well will be discharged and continue treatment up to Day 10 at home. All participants will receive Codivir 20 mg SC 2 x daily.
干预措施: NEWS-2 score (Diagnostic Test)
Covidir
Patient (adults aged ≥18 years) with mild or moderate COVID-19 and flu-symptoms onset within 72 hours prior to inclusion. Treatment begins at the hospital. On the 4th day, participants who are well will be discharged and continue treatment up to Day 10 at home. All participants will receive Codivir 20 mg SC 2 x daily.
干预措施: WHO score (Diagnostic Test)
结局指标
主要结局
Incidence and severity of adverse events related to the investigational product.
时间窗: 28 days
次要结局
- Clinical evolution according to the score of the World Health Organization between admission and days 10 and 28.(up to 28 days)
- Clinical evolution according to NEWS2 score between admission and days 10 and 28.(up to 28 days)
- Evolution of IgM & IgG Anti-SARS-CoV-2.(up to 28 days)
- RT-PCR negative.(up to 28 days)