Study to Evaluate Safety and Efficacy of Carrimycin for Treatment of Severe Coronavirus Disease 2019 (COVID-19) in Hospitalized Patients

• Status: Recruiting
• Trial end date: 2022-07-28
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized, multicenter, placebo-controlled, double-blind clinical study in patients hospitalized due to severe Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shenyang Tonglian Group CO., Ltd

Criteria

Inclusion Criteria:

• Patient with SARS-CoV-2 infection as determined by real time polymerase chain reaction (RT- PCR) or other commercial or public health assay in any specimen taken ≤ 4 days prior to randomization. Patient with a second SARS-CoV-2 episode after resolution of the initial infection may be enrolled if the infection is reconfirmed by RT-PCR and all other eligibility criteria are met. Patient hospitalized, who are requiring supplemental oxygen via nasal cannula, non-invasive ventilation or high-flow oxygen to maintain peripheral oxygen saturation of at least 92% at time of Screening

• Female patient of childbearing potential and male patient with female partner of childbearing potential must agree to use at least one primary form of contraception for the duration of the study

• Ability to provide informed consent personally, or by a legally acceptable representative if the patient is unable to do so

• Patient is willing and able to comply with all required study visits and follow up required by the protocol

• Patient must agree not to enroll in another study of an investigational agent prior to completion of Day 60 of study

Exclusion Criteria:

• Non-hospitalized patients, limitation of activities and/or requiring home oxygen support

• Patient has a creatinine clearance < 50 mL/min using the modification of diet in renal disease formula

• Patient has a known allergy to any study medication or macrolides

• Patient with the presence of hepatitis B surface antigen at Screening

• Patient has a positive hepatitis C antibody test result at Screening

• Patient has a positive hepatitis C RNA test result at Screening

• Patient was seropositive for human immunodeficiency virus

• Patient has been treated with anti-tumor therapy with immunosuppressive effects, which includes chemotherapy, biologics and hormonal therapy in the past 30 days prior to Screening

• Patient has used a macrolide in the week prior to Screening

• Patient has used antiviral drugs which are not part of SOC < 24 hours prior to Day 1

• Patient has used medications that are narrow therapeutic index cytochrome P450 (CYP) substrates or are strong inhibitors and/or inducers of CYP3A4 or CYP3A5 and organic anion transporting polypeptide (OATP)1B1 or OATP1B3 < 2 days prior to Day 1 and/or plans to initiate such medications during the treatment period

• Patient has consumed foods and/or used herbal medicines with strong CYP3A4 or CYP3A5 effects

• Patient who, in the judgment of the Investigator, will be unlikely or unable to comply with the requirements of this protocol through Day 60

• Female patient who is pregnant or breastfeeding

• Critical patient with a life expectancy < 48 hours

• Patient who has received an organ transplant in the past 6 months prior to Screening or is on the waiting list for organ transplantation

• Patient with evidence of multiorgan failure (defined as two or more organs failing) or septic shock

• Patient requiring mechanical ventilation or extracorporeal membrane oxygenation at Screening

• Patient has a mean corrected QT interval using Fridericia's formula (QTcF) of > 450 msec (for male patients) and > 470 msec (for female patients) at Screening

• Patient who has a history of alcohol abuse within 3 months prior to the study as judged by the Investigator