A Phase 3 interventional study of Carrimycin and Placebo in Coronavirus Disease 2019, sponsored by Shenyang Tonglian Group CO., Ltd. Terminated at 17 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-02-23.
Sponsored by Shenyang Tonglian Group CO., Ltd · Phase 3, Interventional, and Treatment
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.
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.
929 studies on the registry are indexed under Coronavirus Infections; 50 are open to participants now.
This study's enrollment of 93 is below the median of 107 across 541 interventional studies indexed under Coronavirus Infections.
Browse Coronavirus Infections studies →This is the only study on the registry with Shenyang Tonglian Group CO., Ltd as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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:
Patients will receive oral dose of 400 mg carrimycin once-daily and SOC for 14 days.
Drug: Carrimycin
Patients will receive oral dose of Placebo once-daily and SOC for 14 days.
Drug: Placebo
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 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.
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
Time frame: Up to Day 28
Time to recovery based on 8-category ordinal scale
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.
Time frame: From screening Day (Day -4 to Day -1) until Day 28
Time to recovery based on the Breathlessness, Cough and Sputum Scale (BCSS)
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.
Time frame: From screening Day (Day -4 to Day -1) until Day 28
Time to symptom improvement
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.
Time frame: From screening Day (Day -4 to Day -1) until Day 28
Length of hospital stay (in days)
To evaluate length of hospital stay between patients receiving carrimycin vs placebo.
Time frame: From Screening Day (Day -4 to Day -1) until Day 60 or Early Withdrawal
Time to discharge (in days)
To evaluate time to discharge between patients receiving carrimycin vs placebo.
Time frame: 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
To evaluate mortality rates between patients receiving carrimycin vs placebo.
Time frame: At Days 14 and 28
Changes from baseline in sequential organ failure assessment (SOFA) score
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.
Time frame: 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
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.
Time frame: From screening Day (Day -4 to Day -1) until Day 28
Mean changes in BCSS score during the study period
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.
Time frame: From screening Day (Day -4 to Day -1) until Day 28
Change from baseline in respiratory rate
To evaluate the improvement for specific clinical parameters including respiratory rate.
Time frame: From screening Day (Day -4 to Day -1) until Day 60 and at Early Withdrawal
Change from baseline in temperature
To evaluate the improvement for specific clinical parameters including fever.
Time frame: 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)
To evaluate the safety and tolerability of the carrimycin and to describe the safety profile of treatments as reflected by AEs and SAEs.
Time frame: From screening Day (Day -4 to Day -1) until Day 28 and until Day 60
This study is terminated, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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