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

NCT04672564 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: TLKLXG202001
• Study Type: interventional
• Target: 93
• Locations: 6 countries
• Sites: 17

Brief 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.

Conditions

Coronavirus Disease 2019

Keywords

Severe Acute Respiratory Syndrome Coronavirus 2; Safety; Novel coronavirus; Carrimycin; Remdesivir

Outcome Measures

Primary Outcomes (1)

• Time to patient not requiring supplemental oxygen up to 28 days after randomisation

  To evaluate the efficacy of carrimycin with SOC compared to placebo with SOC in patients hospitalized with severe SARS-CoV-2 pneumonia. Patients must have remained off of supplemental oxygen for at least 48 hours and remain off of oxygen until Day 28

  Up to Day 28

Secondary Outcomes (12)

• Time to recovery based on 8-category ordinal scale

  From screening Day (Day -4 to Day -1) until Day 28

• Time to recovery based on the Breathlessness, Cough and Sputum Scale (BCSS)

  From screening Day (Day -4 to Day -1) until Day 28

• Time to symptom improvement

  From screening Day (Day -4 to Day -1) until Day 28

• Length of hospital stay (in days)

  From Screening Day (Day -4 to Day -1) until Day 60 or Early Withdrawal

• Time to discharge (in days)

  From screening Day (Day -4 to Day -1) until Day 60 and at Early Withdrawal

Study Arms (2)

Carrimycin

EXPERIMENTAL

Patients will receive oral dose of 400 mg carrimycin once-daily and SOC for 14 days.

Drug: Carrimycin

Placebo

PLACEBO COMPARATOR

Patients will receive oral dose of Placebo once-daily and SOC for 14 days.

Drug: Placebo

Interventions

Carrimycin DRUG

Carrimycin (400 mg) will be given once-daily for 14 days (2 x 200 mg tablets) after a meal, if a patient experiences an eating problem, carrimycin will be taken without food.

Carrimycin

Placebo DRUG

Placebo will be given once-daily for 14 days (2 tablets) after a meal, if a patient experiences an eating problem, placebo will be taken without food.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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)

Sponsors & Collaborators

• Shenyang Tonglian Group CO., Ltd: lead

Study Sites (17)

PharmaTex Research, LLC

Amarillo, Texas, 79109, United States

Location

Instituto Médico Platense

La Plata, Buenos Aires, B1900AVG, Argentina

Location

Instituto de Pesquisa Clínica de Campinas

Campinas, São Paulo, 13060-080, Brazil

Location

Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base

São José do Rio Preto, São Paulo, 15090-000, Brazil

Location

Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca"

Guadalajara, Jalisco, 44340, Mexico

Location

EME RED Hospitalaria

Mérida, Yucatán, 97000, Mexico

Location

Hospital Dr. Agustin O'Horan

Mérida, Yucatán, 97000, Mexico

Location

St. Paul's Hospital of Iloilo, Inc.

Iloilo City, Iloilo, 5000, Philippines

Location

Makati Medical Center - Infectious Diseases

Makati City, National Capital Region, 1229, Philippines

Location

San Juan De Dios Hospital

Pasay, National Capital Region, 1300, Philippines

Location

Veterans Memorial Medical Center

Quezon City, National Capital Region, 0870, Philippines

Location

Quirino Memorial Medical Center

Quezon City, National Capital Region, 1109, Philippines

Location

Chernihivska miska likarnia #2

Chernihiv, Chernihiv Oblast, 14034, Ukraine

Location

Ivano-Frankivsk Central City Clinical Hospital

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

Oblasnyi klinichnyi ftyziopulmonolohichnyi tsentr

Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018, Ukraine

Location

Komunalne Pidpryiemstvo "Poltavska Oblasna Klinichna Infektsiina Likarnia" Poltavskoi Oblasnoi Rady

Poltava, Poltava Oblast, 36011, Ukraine

Location

Volyn Regional Clinical Hospital

Lutsk, Volyn Oblast, 43005, Ukraine

Location

MeSH Terms

Conditions

COVID-19

Interventions

carrimycin

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 17, 2020
• Study Start: March 30, 2021
• Primary Completion: March 24, 2022
• Study Completion: May 9, 2022
• Last Updated: February 23, 2023

Record last verified: 2023-02

Locations

US (1); UA (5); AR (1); ME (3); PH (5); BR (2)