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Trial record 2 of 3 for:    carrimycin

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

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ClinicalTrials.gov Identifier: NCT04672564
Recruitment Status : Recruiting
First Posted : December 17, 2020
Last Update Posted : April 8, 2021
Sponsor:
Information provided by (Responsible Party):
Shenyang Tonglian Group CO., Ltd

Tracking Information
First Submitted Date  ICMJE December 16, 2020
First Posted Date  ICMJE December 17, 2020
Last Update Posted Date April 8, 2021
Actual Study Start Date  ICMJE March 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 16, 2020)
Percentage of patients alive without need for supplemental oxygen and ongoing in patient-medical care (SOC treatment for COVID-19) at Day 28 [ Time Frame: At Day 28 ]
To evaluate the efficacy and safety of carrimycin compared to SOC in patients hospitalized with severe SARS-CoV-2 pneumonia.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 16, 2020)
  • Time to recovery [ Time Frame: From screening Day (Day -2 to Day -1) until Day 28 ]
    To evaluate efficacy of carrimycin administered for treatment of severe COVID-19 in hospitalized patients between patients receiving carrimycin vs placebo. 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.
  • Mean difference from baseline (Days -2 to -1) to Day 28 as per the 8 category ordinal scale [ Time Frame: Screening Day (Day -2 to Day -1) until Day 28 ]
    To evaluate the efficacy of carrimycin administered for the treatment of severe COVID-19 in hospitalized patients between patients receiving carrimycin vs placebo. The 8-Category ordinal scale score ranges from 1 to 8. Score 1 indicates: 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 (ECMO) and score 8 indicates: Death. Higher scores indicate worse outcome
  • Change in lung imaging [ Time Frame: Days 7, 14 and 28 ]
    To evaluate the efficacy of carrimycin administered for the treatment of severe COVID-19 in hospitalized patients between patients receiving carrimycin vs placebo. Radiological imaging (lung computed tomography scan and chest X-ray) will be used to determine change in lung imaging.
  • Negative conversion ratio of SARS-CoV-2 RNA in nasopharyngeal samples after treatment. [ Time Frame: Days 3, 7 and 14 ]
    To evaluate the efficacy of carrimycin administered for the treatment of severe COVID-19 in hospitalized patients between patients receiving carrimycin vs placebo. To evaluate the change in viral load between treatment arms and to evaluate the relationship between change in viral load over time with time to clinical recovery.
  • Improvement in sequential organ failure assessment (SOFA) score [ Time Frame: Days 3, 7, 10, 14 and 28 after treatment ]
    To evaluate the efficacy of carrimycin administered for the treatment of severe COVID-19 in hospitalized patients between patients receiving carrimycin vs placebo. The SOFA score ranges from 0 to 4. Lower score predicts better organ functioning and higher score represents severe organ failure.
  • Length of hospital stay (in days) [ Time Frame: From Screening Day (Day -2 to Day -1) until Day 60 or Early Withdrawal ]
    To evaluate length of hospital stay and to evaluate time to successful discharge between patients receiving carrimycin vs placebo.
  • Number of patients with all cause mortality at Days 14 and 28 [ Time Frame: From Screening Day (Day -2 to Day -1) until Day 60 or Early Withdrawal ]
    To evaluate mortality rates between patients receiving carrimycin vs placebo.
  • Number of patients with adverse event (AEs) and Serious adverse events (SAEs) [ Time Frame: Day 28 and 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.
  • Number of patients with changes in routine electrocardiogram (ECG) from Day 1 up to Day 14 [ Time Frame: Day 1 until Day 14 ]
    To evaluate the safety and tolerability of the carrimycin and to describe the safety profile of treatments. The routine ECG will include heart rate, QTc interval, ST segment and T wave changes
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Safety and Efficacy of Carrimycin for Treatment of Severe Coronavirus Disease 2019 (COVID-19) in Hospitalized Patients
Official Title  ICMJE 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
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Coronavirus Disease 2019
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Experimental: Carrimycin
    Patients will receive oral dose of 400 mg carrimycin once-daily and SOC for 14 days.
    Intervention: Drug: Carrimycin
  • Placebo Comparator: Placebo
    Patients will receive oral dose of Placebo once-daily and SOC for 14 days.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 16, 2020)
300
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date June 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  • Patient diagnosed with viral pneumonia other than COVID-19
  • 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 has positive immunodeficiency virus antibody test
  • Patient has been treated with anti-tumor 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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Henry Wang 86 188 0403 2009 Hwang0404@hotmail.com
Listed Location Countries  ICMJE Argentina,   Brazil,   Colombia,   India,   Mexico,   Peru,   Philippines,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04672564
Other Study ID Numbers  ICMJE TLKLXG202001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shenyang Tonglian Group CO., Ltd
Study Sponsor  ICMJE Shenyang Tonglian Group CO., Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shenyang Tonglian Group CO., Ltd
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP