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

February 22, 2023 updated by: Shenyang Tonglian Group CO., Ltd

A Phase 3, Randomized, Multicenter, Placebo-controlled, Double-blind Clinical Study of the Safety and Efficacy of Carrimycin for Treatment of Severe COVID-19 in Hospitalized Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Eligible 300 hospitalized patients with confirmed severe SARS-CoV-2 infection will be randomly assigned (1:1) to receive 14 days treatment of 400 mg carrimycin and standard of care (SOC) or placebo and SOC.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
93

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • La Plata, Buenos Aires, Argentina, B1900AVG
        • Instituto Medico Platense
  • Brazil
    • São Paulo
      • Campinas, São Paulo, Brazil, 13060-080
        • Instituto de Pesquisa Clínica de Campinas
      • São José do Rio Preto, São Paulo, Brazil, 15090-000
        • Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44340
        • Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca"
    • Yucatán
      • Mérida, Yucatán, Mexico, 97000
        • Eme Red Hospitalaria
      • Mérida, Yucatán, Mexico, 97000
        • Hospital Dr. Agustin O'Horan
  • Philippines
    • Iloilo
      • Iloilo City, Iloilo, Philippines, 5000
        • St. Paul's Hospital of Iloilo, Inc.
    • National Capital Region
      • Makati City, National Capital Region, Philippines, 1229
        • Makati Medical Center - Infectious Diseases
      • Pasay, National Capital Region, Philippines, 1300
        • San Juan De Dios Hospital
      • Quezon, National Capital Region, Philippines, 1109
        • Quirino Memorial Medical Center
      • Quezon City, National Capital Region, Philippines, 0870
        • Veterans Memorial Medical Center
  • Ukraine
    • Chernihivs'ka Oblast'
      • Chernihiv, Chernihivs'ka Oblast', Ukraine, 14034
        • Chernihivska miska likarnia #2
    • Ivano-Frankivs'ka Oblast'
      • Ivano-Frankivsk, Ivano-Frankivs'ka Oblast', Ukraine, 76018
        • Ivano-Frankivsk Central City Clinical Hospital
      • Ivano-Frankivsk, Ivano-Frankivs'ka Oblast', Ukraine, 76018
        • Oblasnyi klinichnyi ftyziopulmonolohichnyi tsentr
    • Poltavs'ka Oblast'
      • Poltava, Poltavs'ka Oblast', Ukraine, 36011
        • Komunalne Pidpryiemstvo "Poltavska Oblasna Klinichna Infektsiina Likarnia" Poltavskoi Oblasnoi Rady
    • Volyns'ka Oblast'
      • Lutsk, Volyns'ka Oblast', Ukraine, 43005
        • Volyn Regional Clinical Hospital
  • United States
    • Texas
      • Amarillo, Texas, United States, 79109
        • PharmaTex Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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. 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

Exclusion Criteria:

  • 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:

    1. Narrow therapeutic index substrates of cytochrome P450 (CYP) enzymes
    2. 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)
    3. Strong inhibitors and/or inducers of enzymes CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP3A4/5
    4. Strong inhibitors of transporters OATP1B1 and OATP1B3
    5. 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Carrimycin
Patients will receive oral dose of 400 mg carrimycin once-daily and SOC for 14 days.
Drug: Carrimycin
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.
Placebo Comparator: Placebo
Patients will receive oral dose of Placebo once-daily and SOC for 14 days.
Drug: Placebo
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to patient not requiring supplemental oxygen up to 28 days after randomisation
Time Frame: Up to Day 28
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to recovery based on 8-category ordinal scale
Time Frame: From screening Day (Day -4 to Day -1) until Day 28
To describe the difference in time to pre-defined symptom improvement compared to placebo, based on 8-category ordinal scale. Time to recovery is defined as time point when a patient reaches level 3 or lower on the 8-Category ordinal scale and does not return to a level > 3 during the 28-day period. The 8-Category ordinal scale score ranges from 1 to 8. Score 1: Not hospitalized, no limitations on activities; 2: Not hospitalized, limitation on activities, home oxygen requirement or both; 3: Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care; 4: Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care; 5: Hospitalized, requiring supplemental oxygen; 6: Hospitalized, requiring noninvasive ventilation or high flow oxygen devices; 7: Hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation and score 8: Death. Higher scores indicate worse outcome.
From screening Day (Day -4 to Day -1) until Day 28
Time to recovery based on the Breathlessness, Cough and Sputum Scale (BCSS)
Time Frame: From screening Day (Day -4 to Day -1) until Day 28
To describe the difference in time to pre-defined symptom improvement compared to placebo based on the BCSS. The BCSS is a three-item questionnaire rating breathlessness, cough and sputum on a 5-point Likert scale from 0 (no symptoms) to 4 (severe symptoms). A reduction in the mean total BCSS score represents a substantial symptomatic improvement.
From screening Day (Day -4 to Day -1) until Day 28
Time to symptom improvement
Time Frame: From screening Day (Day -4 to Day -1) until Day 28
To describe the difference in time to pre-defined symptom improvement compared to placebo, based on the BCSS. Time to symptom improvement can be considered when the score of a patient has a reduction of 1 with 2 consecutive ratings on the BCSS. The BCSS is a three-item questionnaire rating breathlessness, cough and sputum on a 5-point Likert scale from 0 (no symptoms) to 4 (severe symptoms). A reduction in the mean total BCSS score represents a substantial symptomatic improvement.
From screening Day (Day -4 to Day -1) until Day 28
Length of hospital stay (in days)
Time Frame: From Screening Day (Day -4 to Day -1) until Day 60 or Early Withdrawal
To evaluate length of hospital stay between patients receiving carrimycin vs placebo.
From Screening Day (Day -4 to Day -1) until Day 60 or Early Withdrawal
Time to discharge (in days)
Time Frame: From screening Day (Day -4 to Day -1) until Day 60 and at Early Withdrawal
To evaluate time to discharge between patients receiving carrimycin vs placebo.
From screening Day (Day -4 to Day -1) until Day 60 and at Early Withdrawal
Number of patients with all cause mortality at Days 14 and 28
Time Frame: At Days 14 and 28
To evaluate mortality rates between patients receiving carrimycin vs placebo.
At Days 14 and 28
Changes from baseline in sequential organ failure assessment (SOFA) score
Time Frame: From baseline (Day -4 to Day -1) Days 3, 7, 10, 14 and 28 after treatment
To evaluate the improvement for specific clinical parameters including fever, respiratory rate, oxygen saturation, breathlessness, cough and sputum production. The SOFA score ranges from 0 to 4. Lower score predicts better organ functioning and higher score represents severe organ failure.
From baseline (Day -4 to Day -1) Days 3, 7, 10, 14 and 28 after treatment
Percentage of patients who reach level 2 or lower at Day 28 on the 8 category ordinal scale
Time Frame: From screening Day (Day -4 to Day -1) until Day 28
The 8-Category ordinal scale score ranges from 1 to 8. Score 1: Not hospitalized, no limitations on activities; 2: Not hospitalized, limitation on activities, home oxygen requirement or both; 3: Hospitalized, not requiring supplemental oxygen and no longer requiring ongoing medical care; 4: Hospitalized, not requiring supplemental oxygen but requiring ongoing medical care; 5: Hospitalized, requiring supplemental oxygen; 6: Hospitalized, requiring noninvasive ventilation or high flow oxygen devices; 7: Hospitalized, receiving invasive mechanical ventilation or extracorporeal membrane oxygenation and score 8: Death. Higher scores indicate worse outcome.
From screening Day (Day -4 to Day -1) until Day 28
Mean changes in BCSS score during the study period
Time Frame: From screening Day (Day -4 to Day -1) until Day 28
To evaluate the improvement for specific clinical parameters including breathlessness, cough and sputum production. The BCSS is a three-item questionnaire rating breathlessness, cough and sputum on a 5-point Likert scale from 0 (no symptoms) to 4 (severe symptoms). A reduction in the mean total BCSS score represents a substantial symptomatic improvement.
From screening Day (Day -4 to Day -1) until Day 28
Change from baseline in respiratory rate
Time Frame: From screening Day (Day -4 to Day -1) until Day 60 and at Early Withdrawal
To evaluate the improvement for specific clinical parameters including respiratory rate.
From screening Day (Day -4 to Day -1) until Day 60 and at Early Withdrawal
Change from baseline in temperature
Time Frame: From screening Day (Day -4 to Day -1) until Day 60 and at Early Withdrawal
To evaluate the improvement for specific clinical parameters including fever.
From screening Day (Day -4 to Day -1) until Day 60 and at Early Withdrawal
Number of patients with adverse event (AEs) and Serious adverse events (SAEs)
Time Frame: From screening Day (Day -4 to Day -1) until Day 28 and until Day 60
To evaluate the safety and tolerability of the carrimycin and to describe the safety profile of treatments as reflected by AEs and SAEs.
From screening Day (Day -4 to Day -1) until Day 28 and until Day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shenyang Tonglian Group CO., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 24, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 9, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2020

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TLKLXG202001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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