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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Coronavirus Disease 2019

In brief

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.

Key facts

Study ID

NCT04672564

Run by

Shenyang Tonglian Group CO., Ltd

People needed

93

Starts

2021-03-30

Expected to finish

2022-05-09

Last updated by the study team

2023-02-23

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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. Onset of symptoms of COVID-19 must be 14 or fewer days prior to randomization. Patient with a second SARS-CoV-2 episode after resolution of the initial infection may be enrolled if the initial infection had clearly resolved, re-infection is reconfirmed by RT-PCR and all other eligibility criteria are met
• Hospitalized patient who requires oxygen supplementation via either low-flow oxygen device (such as nasal cannula or face mask), high flow oxygen therapy (including high-flow nasal cannula), or non invasive ventilation to maintain peripheral oxygen saturation of at least 94%. The patient must have had such an oxygen requirement for 2 days or fewer at the time of Screening, and the oxygen requirement must be non-improving (worsening or stable) in the Investigator's judgement at the time of Screening and randomization
• 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

You may not qualify if…

• Non-hospitalized patients, including those requiring home oxygen support
• Patient has a creatinine clearance < 50 mL/min/1.73m\^2 using the modification of diet in renal disease formula
• Patient cannot take the study drug by mouth and needs to be administered by nasogastric tube at Screening.
• Patient has a known allergy to any study medication or macrolides
• Patient with known medical history of hepatitis B or, if tested, presence of hepatitis B surface antigen at Screening
• Patient has a known medical history of hepatitis C or positive hepatitis C antibody test result at Screening (if obtained)
• Patient has a positive hepatitis C RNA test result at Screening
• Patient has a known medical history of human immunodeficiency virus (HIV) infection or was seropositive for human immunodeficiency virus (if tested)
• 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 receiving hemoperfusion or with anticipated use of hemoperfusion (including when hemoperfusion is a part of SOC)
• Patient has used the following types of medications < 2 days prior to Day 1 and/or plans to initiate such medications during the treatment period without an appropriate alternative therapy:
• Narrow therapeutic index substrates of cytochrome P450 (CYP) enzymes
• Narrow therapeutic index substrates of major transporters: organic anion transporting polypeptide 1B1 and 1B3 (OATP1B1, OATP1B3), organic anion transporter 1 and 3 (OAT1, OAT3), organic cation transporter 2 (OCT2) and multidrug and toxin extrusion proteins 1 and 2-K (MATE1, MATE2K)
• Strong inhibitors and/or inducers of enzymes CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4/5
• Strong inhibitors of transporters OATP1B1 and OATP1B3
• Note: strong inhibitors of OAT1/OAT3, OCT2 and MATE1/MATE2K should be avoided when possible, but when unavoidable investigators may assess the risks and benefits and to continue treatment with such medications under close observation for adverse events
• 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

Where it is running

• PharmaTex Research, LLC — Amarillo, Texas, United States
• Instituto Médico Platense — La Plata, Buenos Aires, Argentina
• Instituto de Pesquisa Clínica de Campinas — Campinas, São Paulo, Brazil
• Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base — São José do Rio Preto, São Paulo, Brazil
• Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca" — Guadalajara, Jalisco, Mexico
• EME RED Hospitalaria — Mérida, Yucatán, Mexico
• Hospital Dr. Agustin O'Horan — Mérida, Yucatán, Mexico
• St. Paul's Hospital of Iloilo, Inc. — Iloilo City, Iloilo, Philippines
• Makati Medical Center - Infectious Diseases — Makati City, National Capital Region, Philippines
• San Juan De Dios Hospital — Pasay, National Capital Region, Philippines
• Veterans Memorial Medical Center — Quezon City, National Capital Region, Philippines
• Quirino Memorial Medical Center — Quezon City, National Capital Region, Philippines
• Chernihivska miska likarnia #2 — Chernihiv, Chernihiv Oblast, Ukraine
• Ivano-Frankivsk Central City Clinical Hospital — Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
• Oblasnyi klinichnyi ftyziopulmonolohichnyi tsentr — Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
• Komunalne Pidpryiemstvo "Poltavska Oblasna Klinichna Infektsiina Likarnia" Poltavskoi Oblasnoi Rady — Poltava, Poltava Oblast, Ukraine
• Volyn Regional Clinical Hospital — Lutsk, Volyn Oblast, Ukraine

Full record on ClinicalTrials.gov

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