Coronavirus Disease 2019Phase 3NCT04672564
Study to Evaluate Safety and Efficacy of Carrimycin for Treatment of Severe Coronavirus Disease 2019 (COVID-19) in Hospitalized Patients
A Phase 3 study testing Carrimycin in people with Coronavirus Disease 2019, run by Shenyang Tonglian Group CO., Ltd at 17 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronavirus Disease 2019
- What is being tested?
- Carrimycin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 93 participants
- Where
- 17 sitesin 6 countries
- Study dates
- 30 Mar 2021to 9 May 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 27Show fewer
- 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
- 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
Trial locations and contacts
17 sites in 6 countries.
17 sites in 6 countries
Philippines5 sites
St. Paul's Hospital of Iloilo, Inc.
Iloilo City, Iloilo, 5000
Makati Medical Center - Infectious Diseases
Makati City, National Capital Region, 1229
San Juan De Dios Hospital
Pasay, National Capital Region, 1300
Veterans Memorial Medical Center
Quezon City, National Capital Region, 0870
Quirino Memorial Medical Center
Quezon City, National Capital Region, 1109
Ukraine5 sites
Chernihivska miska likarnia #2
Chernihiv, Chernihiv Oblast, 14034
Ivano-Frankivsk Central City Clinical Hospital
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018
Oblasnyi klinichnyi ftyziopulmonolohichnyi tsentr
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76018
Volyn Regional Clinical Hospital
Lutsk, Volyn Oblast, 43005
Komunalne Pidpryiemstvo "Poltavska Oblasna Klinichna Infektsiina Likarnia" Poltavskoi Oblasnoi Rady
Poltava, Poltava Oblast, 36011
Mexico3 sites
Nuevo Hospital Civil de Guadalajara "Juan I. Menchaca"
Guadalajara, Jalisco, 44340
EME RED Hospitalaria
Mérida, Yucatán, 97000
Hospital Dr. Agustin O'Horan
Mérida, Yucatán, 97000
Brazil2 sites
Instituto de Pesquisa Clínica de Campinas
Campinas, São Paulo, 13060-080
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto - Hospital de Base
São José do Rio Preto, São Paulo, 15090-000
About this study
Official title: 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.
Read the 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.
- Conditions
- Coronavirus Disease 2019
- Being tested
- Carrimycin, Placebo
- Keywords
- Severe Acute Respiratory Syndrome Coronavirus 2, Safety, Novel coronavirus, Carrimycin, Remdesivir
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CarrimycinDrug
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.
PlaceboDrug
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 group | Role | What they receive |
|---|---|---|
| Carrimycin | Experimental | Patients will receive oral dose of 400 mg carrimycin once-daily and SOC for 14 days. Receives: Drug: Carrimycin |
| Placebo | Placebo comparator | Patients will receive oral dose of Placebo once-daily and SOC for 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to Day 28
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From screening Day (Day -4 to Day -1) until Day 28 and until Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start30 Mar 2021
- Primary completion24 Mar 2022
- Study completion9 May 2022
Why it stopped: sponsor strategy change
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shenyang Tonglian Group CO., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04672564
- Sponsor's protocol ID
- TLKLXG202001
- Status last verified
- Feb 2023
- First submitted
- 16 Dec 2020
- Last updated
- 23 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04672564
- Acronym / sponsor ID
- TLKLXG202001
- Conditions
- Coronavirus Disease 2019
- Keywords
- Severe Acute Respiratory Syndrome Coronavirus 2, Safety, Novel coronavirus, Carrimycin, Remdesivir
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: sponsor strategy change
- Enrolment
- 93 participants (actual)
- Lead sponsor
- Shenyang Tonglian Group CO., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Mar 2021 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 9 May 2022 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carrimycin | Experimental | Drug: CarrimycinPatients will receive oral dose of 400 mg carrimycin once-daily and SOC for 14 days. |
| Placebo | Placebo comparator | Drug: PlaceboPatients will receive oral dose of Placebo once-daily and SOC for 14 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (27 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CarrimycinCarrimycin (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 | Carrimycin |
| PlaceboPlacebo 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. | Drug | Placebo |
Primary outcome
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
12 secondary outcomes
Time to recovery based on 8-category ordinal scale
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)
Time frame: 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
Length of hospital stay (in days)
Time frame: 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
Number of patients with all cause mortality at Days 14 and 28
Time frame: 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
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
Mean changes in BCSS score during the study period
Time frame: 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
Change from baseline in temperature
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)
Time frame: From screening Day (Day -4 to Day -1) until Day 28 and until Day 60
Results and safety
The study was stopped early (reason given: sponsor strategy change). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
17 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Carrimycin in people with Coronavirus Disease 2019, run by Shenyang Tonglian Group CO., Ltd at 17 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 23 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Philippines, Ukraine, Mexico, Brazil, United States and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: sponsor strategy change). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to patient not requiring supplemental oxygen up to 28 days after randomisation (time frame: Up to Day 28). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2023.