COVID-19Phase 3NCT05716425

Study to Assess the Efficacy and Safety of STI-1558 in Adult Subjects With Mild or Moderate (COVID-19)

A Phase 3 study testing STI-1558 in people with COVID-19, run by Zhejiang ACEA Pharmaceutical Co. Ltd. at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: COVID-19
What is being tested?: STI-1558
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 1,218 participants
Where: 2 sitesChina
Study dates: 8 Feb 2023to 26 Jul 2023
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

Males or females aged ≥18 years;
Subjects comply with the diagnostic criteria for mild or moderate COVID-19 specified in the Protocol for the Diagnosis and Treatment of Novel Coronavirus Pneumonia (Trial Version 9) released by China's National Health Commission;
First presence of positive RT-PCR or rapid antigen assay for SARS-CoV-2 with nasopharyngeal or oropharyngeal swabs within 4 days prior to the first dose (≤4 days from the first dose);
First presence of at least 1 of 14 symptoms of COVID-19 within 3 days prior to the first dose (≤3 days/72 hours from the first dose) ;
Subjects with at least 2 of 11 target symptoms of COVID-19 within 24 hours prior to the first dose (≤24 hours from the first dose), including at least 1 designated symptom (Stuffy or runny nose, Sore throat or dry throat, Cough, Feeling hot or feverish, Shortness of breath or difficulty breathing), and score of at least 1 designated symptom ≥2 ;
Women of childbearing potential (WOCBP) (women of non-childbearing potential defined as women who have undergone hysterectomy or bilateral oophorectomy or bilateral salpingectomy or bilateral tubal ligation/closure, or who are infertile due to a congenital or acquired condition, or sexually mature women spontaneously menopausal for ≥ 12 months) must have a negative pregnancy test during the screening period;
Female subjects of childbearing potential or male subjects whose partners are of childbearing potential must agree to use a highly effective contraceptive method from screening to 30 days after the last dose;
Can understand and abide by the procedures and methods of this clinical trial.

Who cannot join

Known allergy to any ingredient of the study drug;
Subjects comply with the diagnostic criteria for severe or critical COVID-19 specified in the Protocol for the Diagnosis and Treatment of Novel Coronavirus Pneumonia (Trial Version 9) released by China's National Health Commission prior to the first dose;
Subjects urgently require or is expected to require nasal high-flow oxygen therapy or non-invasive positive pressure ventilation, invasive mechanical ventilation or ECMO prior to the first dose;
Subjects with abnormal liver function at screening: total bilirubin ≥ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × ULN;
Subjects with active or uncontrolled hepatopathy: including cirrhosis, Child-Pugh grade B or C, acute liver failure, etc.;
Subjects with concomitant severe renal insufficiency (estimated glomerular filtration rate [eGFR]<45 mL/min, calculated using the serum creatinine based Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] equation, refer to Appendix 6 for the calculation formula) or on continuous renal replacement therapy, hemodialysis or peritoneal dialysis;

Show all 21Show fewer

Subjects with impaired immune system (including subjects who are on systemic or inhaled corticosteroids or other immunosuppressants, or subjects with cancer progression or recurrence, or with human immunodeficiency virus [HIV] infection);
Subjects with acute episodes of chronic respiratory diseases (including bronchial asthma, chronic obstructive pulmonary disease, etc.);
Subjects with a history of dysphagia or any gastrointestinal disorder that affects drug adsorption;
Subjects with suspected or confirmed acute systemic infections other than COVID-19 (e.g., concomitant influenza), which may interfere with the evaluation of responses to the study intervention;
Subjects who have underwent major surgery within 14 days prior to the first dose, or have not completely recovered from surgery or plan to undergo surgery during the study period;
Subjects with complications that are, in the opinion of the investigator, life-threatening within 30 days prior to the first dose;
Subjects have received anti-SARS-CoV-2 chemical drugs such as 3CL protease inhibitors or RNA dependent RNA polymerase (RdRp) inhibitors or angiotensin converting enzyme 2 (ACE-2) and transmembrane protease serine 2 (TMPRSS2) degrading agents within 14 days prior to the first dose;
Subjects have received COVID-19 patients' convalescent plasma or COVID-19 human immunoglobulin or interleukin-6 (IL-6) inhibitors or anti-SARS CoV-2 neutralizing antibodies within 30 days or 5 half-lives (whichever is longer) prior to the first dose;
Subjects have had any SARS-CoV-2 vaccination within 3 months prior to the first dose;
Subjects have received any potent inhibitor or inducer of cytochrome P450 (CYP) 3A4 within 28 days or 5 half-lives (whichever is shorter) prior to the first dose;
Subjects who are currently participating in an interventional clinical study of other investigational drugs or devices, including other studies on COVID-19;
Subjects have received any investigational drug within 30 days or 5 half-lives (whichever is longer) prior to the first dose;
Subjects have previously participated in this study or other studies of STI-1558;
Pregnant or lactating women;
Subjects with active serious mental illness, medical disorder or other symptoms/conditions that, in the opinion of the investigator, may affect treatment, compliance or the ability to provide informed consent.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Beijing Ditan Hospital, Capital Medical University
Beijing
Shenzhen Third People 's Hospital
Shenzhen

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of STI-1558 in Adult Subjects With Mild or Moderate (COVID-19)

This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of STI-1558 in adult subjects with mild/moderate COVID-19. One thousand and two hundred adult subjects with mild/moderate COVID-19 (including subjects with high risk factors for progression into severe cases) are planned to be enrolled and randomized in a ratio of 1:1 into the test group or the placebo group (600 in the test group and 600 in the placebo group).

Read the detailed description

One thousand and two hundred adult subjects with mild/moderate COVID-19 (including subjects with high risk factors for progression into severe cases) are planned to be enrolled and randomized in a ratio of 1:1 into the test group or the placebo group. Randomization and stratification factors include clinical type (mild vs. moderate) of COVID-19, high risk factors for severe disease (with vs. without), history of SARS-CoV-2 vaccination or infection (yes vs. no). Subjects in the test group will receive STI-1558, and subjects in the placebo group will receive STI-1558 placebo. STI-1558 and STI-1558 placebo will be orally administered under fasting condition twice daily (BID) for 5 days (10 doses in total) at a dose of 600 mg and 0 mg, respectively; the two doses administered will be at a minimum interval of 8 hours (≥8 h). Efficacy and safety will be assessed until D29 after the first dose.

Conditions: COVID-19
Being tested: STI-1558, STI-1558 placebo
Medical subject headings: COVID-19

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

STI-1558Drug
STI-1558 will be orally administered under fasting condition twice daily (BID) for 5 days (10 doses in total) at a dose of 600 mg, respectively; the two doses administered will be at a minimum interval of 8 hours (≥8 h). Efficacy and safety will be assessed until D29 after the first dose.
STI-1558 placeboDrug
STI-1558 placebo will be orally administered under fasting condition twice daily (BID) for 5 days (10 doses in total) at a dose of 0 mg, respectively; the two doses administered will be at a minimum interval of 8 hours (≥8 h). Efficacy and safety will be assessed until D29 after the first dose.

Study groups in NCT05716425
Study group	Role	What they receive
Arm A	Experimental	* STI-1558 * n=600 Receives: Drug: STI-1558
Arm B	Placebo comparator	* Placebo * n=600 Receives: Drug: STI-1558 placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Time from the first dose to sustained recovery from 11 target symptoms of COVID-19.
Sustained recovery from 11 target symptoms of COVID-19: the score of each of the 11 target symptoms of COVID-19 in the subject is 0 for ≥2 days.
Measured: Time from the first dose to the day when the score of each of the 11 target symptoms of COVID-19 is 0.

Secondary outcomes (8)

Change from baseline in the SARS-CoV-2 RNA load (reverse transcriptase polymerase chain reaction [RT-PCR] assay) at each visit point from the first dose to Day4 and Day6.
Change from baseline in the SARS-CoV-2 RNA load at each visit point.
Measured: From the first dose to Day4 and Day6.
Time from the first dose to sustained recovery from 5 designated symptoms of COVID-19.
Sustained recovery from 5 designated symptoms of COVID-19: the score of each of the 5 designated symptoms of COVID-19 (fever or feeling hot, cough, nasal obstruction or rhinorrhoea, pain pharynx or dry throat, shortness of breath or dyspnea) in the subject is 0 for ≥2 days.
Measured: Time from the first dose to the day when the score of each of the 5 designated symptoms of COVID-19 is 0.
Proportion of subjects with negative SARS-CoV-2 RNA conversion at each visit from the first dose to Day14.
Proportion of subjects with negative SARS-CoV-2 RNA conversion at each visit.
Measured: From the first dose to Day14.
Area under the SARS-CoV-2 RNA load-time curve (AUC) between the first dose and Day6.
Area under the SARS-CoV-2 RNA load-time curve (AUC) .
Measured: From the first dose to Day6.
1.Time from the first dose to sustained remission of 11 target symptoms of COVID-19. 2.Time from the first dose to sustained remission of 5 designated symptoms of COVID-19. 3.Time from the first dose to sustained remission of 14 symptoms of COVID-19.
Sustained remission of the symptoms of COVID-19: the score of each of the symptoms of COVID-19 in the subject is 0 or 1 for ≥2 days; time from the first dose to sustained remission of the symptoms of COVID-19: time from the first dose to the day when the score of each of the symptoms of COVID-19 is 0 or 1.
Measured: From the first dose to the day when the score of each of the COVID-19 symptoms is 0 or 1.
1.Time to sustained recovery/sustained remission. 2.Proportion of subjects with sustained recovery/sustained remission. 3.Proportion of each of 11 target symptoms by severity. 4.Scores of 11 target symptoms -time AUC from the first dose to Day14.
1. Sustained recovery from 11 target symptoms of COVID-19: the score of each of the 11 target symptoms of COVID-19 in the subject is 0 for ≥2 days; time from the first dose to sustained recovery from 11 target symptoms of COVID-19: time from the first dose to the day when the score of each of the 11 target symptoms of COVID-19 is 0.
2. Sustained remission of 11 target symptoms of COVID-19: the score of each of the 11 target symptoms of COVID-19 in the subject is 0 or 1 for ≥2 days; time from the first dose to sustained remission of 11 target symptoms of COVID-19: time from the first dose to the day when the score of each of the 11 target symptoms of COVID-19 is 0 or 1.
Measured: From the first dose to Day29/Day14.
Proportion of subjects: 1.Progressing into severe COVID-19. 2.Undergoing COVID-19 associated hospitalization or all-cause deaths. 3.Requiring assisted oxygen inhalation/ mechanical ventilation/ECMO. 4.Admitted into the ICU. 5.Number of days in ICU.
Proportion of subjects progressing into severe COVID-19/undergoing COVID-19 associated hospitalization or all-cause deaths/requiring assisted oxygen inhalation/admitted into the intensive care unit (ICU) / requiring mechanical ventilation/extracorporeal membrane oxygenation.
Measured: From the first dose to Day29.
During treatment: 1. Incidence of all adverse events (AEs) and serious adverse events (SAEs); 2. Any clinically significant abnormality in vital signs or physical examination; 3. Any clinically significant abnormality in laboratory tests, ECG, etc.
Incidence of all AEs and SAEs;Any clinically significant abnormality in vital signs or physical examination or laboratory tests, ECG, etc.
Measured: From the signing of informed consent to the 29 th day of administration.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Feb 202326 Jul 2023

First posted8 Feb 2023
Study start8 Feb 2023
Primary completion26 Jul 2023
Study completion26 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for COVID-19Studies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,218 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05716425
Sponsor's protocol ID: MPR-COV-301CN
Status last verified: May 2024
First submitted: 3 Feb 2023
Last updated: 14 May 2024
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jiang R, Han B, Xu W, Zhang X, Peng C, Dang Q, Sun W, Lin L, Lin Y, Fan L, Lv D, Shao L, Chen Y, Qiu Y, Han L, Kong W, Li G, Wang K, Peng J, Lin B, Tong Z, Lu X, Wang L, Gao F, Feng J, Li Y, Ma X, Wang J, Wang S, Shen W, Wang C, Yan K, Lin Z, Jin C, Mao L, Liu J, Kushnareva Y, Kotoi O, Zhu Z, Royal M, Brunswick M, Ji H, Xu X, Lu H. Olgotrelvir as a Single-Agent Treatment of Nonhospitalized Patients with Covid-19. NEJM Evid. 2024 Jun;3(6):EVIDoa2400026. doi: 10.1056/EVIDoa2400026. Epub 2024 May 28.
PubMed 38804790
Mao L, Shaabani N, Zhang X, Jin C, Xu W, Argent C, Kushnareva Y, Powers C, Stegman K, Liu J, Xie H, Xu C, Bao Y, Xu L, Zhang Y, Yang H, Qian S, Hu Y, Shao J, Zhang C, Li T, Li Y, Liu N, Lin Z, Wang S, Wang C, Shen W, Lin Y, Shu D, Zhu Z, Kotoi O, Kerwin L, Han Q, Chumakova L, Teijaro J, Royal M, Brunswick M, Allen R, Ji H, Lu H, Xu X. Olgotrelvir, a dual inhibitor of SARS-CoV-2 Mpro and cathepsin L, as a standalone antiviral oral intervention candidate for COVID-19. Med. 2024 Jan 12;5(1):42-61.e23. doi: 10.1016/j.medj.2023.12.004. Epub 2024 Jan 4.
PubMed 38181791

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

All COVID-19 trials

Study at a glance

From the registry record, last updated by the sponsor on 14 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of STI-1558 in Adult Subjects With Mild or Moderate (COVID-19)
ClinicalTrials.gov ID: NCT05716425
Acronym / sponsor ID: MPR-COV-301CN
Conditions: COVID-19
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,218 participants (actual)
Lead sponsor: Zhejiang ACEA Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
Study start: 8 Feb 2023 (actual)
Primary completion: 26 Jul 2023 (actual)
Study completion: 26 Jul 2023 (actual)
First posted: 8 Feb 2023 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Arm A	Experimental	Drug: STI-1558* STI-1558 * n=600
Arm B	Placebo comparator	Drug: STI-1558 placebo* Placebo * n=600

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Males or females aged ≥18 years;
Subjects comply with the diagnostic criteria for mild or moderate COVID-19 specified in the Protocol for the Diagnosis and Treatment of Novel Coronavirus Pneumonia (Trial Version 9) released by China's National Health Commission;
First presence of positive RT-PCR or rapid antigen assay for SARS-CoV-2 with nasopharyngeal or oropharyngeal swabs within 4 days prior to the first dose (≤4 days from the first dose);
First presence of at least 1 of 14 symptoms of COVID-19 within 3 days prior to the first dose (≤3 days/72 hours from the first dose) ;
Subjects with at least 2 of 11 target symptoms of COVID-19 within 24 hours prior to the first dose (≤24 hours from the first dose), including at least 1 designated symptom (Stuffy or runny nose, Sore throat or dry throat, Cough, Feeling hot or feverish, Shortness of breath or difficulty breathing), and score of at least 1 designated symptom ≥2 ;

Key exclusion criteria (21 listed)

Known allergy to any ingredient of the study drug;
Subjects comply with the diagnostic criteria for severe or critical COVID-19 specified in the Protocol for the Diagnosis and Treatment of Novel Coronavirus Pneumonia (Trial Version 9) released by China's National Health Commission prior to the first dose;
Subjects urgently require or is expected to require nasal high-flow oxygen therapy or non-invasive positive pressure ventilation, invasive mechanical ventilation or ECMO prior to the first dose;
Subjects with abnormal liver function at screening: total bilirubin ≥ 1.5 × upper limit of normal (ULN), alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 3 × ULN;
Subjects with active or uncontrolled hepatopathy: including cirrhosis, Child-Pugh grade B or C, acute liver failure, etc.;

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
STI-1558STI-1558 will be orally administered under fasting condition twice daily (BID) for 5 days (10 doses in total) at a dose of 600 mg, respectively; the two doses administered will be at a minimum interval of 8 hours (≥8 h). Efficacy and safety will be assessed until D29 after the first dose.	Drug	Arm A
STI-1558 placeboSTI-1558 placebo will be orally administered under fasting condition twice daily (BID) for 5 days (10 doses in total) at a dose of 0 mg, respectively; the two doses administered will be at a minimum interval of 8 hours (≥8 h). Efficacy and safety will be assessed until D29 after the first dose.	Drug	Arm B

Primary outcome

Time from the first dose to sustained recovery from 11 target symptoms of COVID-19.
Time frame: Time from the first dose to the day when the score of each of the 11 target symptoms of COVID-19 is 0.
Sustained recovery from 11 target symptoms of COVID-19: the score of each of the 11 target symptoms of COVID-19 in the subject is 0 for ≥2 days.

8 secondary outcomes

Change from baseline in the SARS-CoV-2 RNA load (reverse transcriptase polymerase chain reaction [RT-PCR] assay) at each visit point from the first dose to Day4 and Day6.
Time frame: From the first dose to Day4 and Day6.
Time from the first dose to sustained recovery from 5 designated symptoms of COVID-19.
Time frame: Time from the first dose to the day when the score of each of the 5 designated symptoms of COVID-19 is 0.
Proportion of subjects with negative SARS-CoV-2 RNA conversion at each visit from the first dose to Day14.
Time frame: From the first dose to Day14.
Area under the SARS-CoV-2 RNA load-time curve (AUC) between the first dose and Day6.
Time frame: From the first dose to Day6.
1.Time from the first dose to sustained remission of 11 target symptoms of COVID-19. 2.Time from the first dose to sustained remission of 5 designated symptoms of COVID-19. 3.Time from the first dose to sustained remission of 14 symptoms of COVID-19.
Time frame: From the first dose to the day when the score of each of the COVID-19 symptoms is 0 or 1.
1.Time to sustained recovery/sustained remission. 2.Proportion of subjects with sustained recovery/sustained remission. 3.Proportion of each of 11 target symptoms by severity. 4.Scores of 11 target symptoms -time AUC from the first dose to Day14.
Time frame: From the first dose to Day29/Day14.
Proportion of subjects: 1.Progressing into severe COVID-19. 2.Undergoing COVID-19 associated hospitalization or all-cause deaths. 3.Requiring assisted oxygen inhalation/ mechanical ventilation/ECMO. 4.Admitted into the ICU. 5.Number of days in ICU.
Time frame: From the first dose to Day29.
During treatment: 1. Incidence of all adverse events (AEs) and serious adverse events (SAEs); 2. Any clinically significant abnormality in vital signs or physical examination; 3. Any clinically significant abnormality in laboratory tests, ECG, etc.
Time frame: From the signing of informed consent to the 29 th day of administration.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2024.
Derived from this study: PubMed 38804790Jiang R, Han B, Xu W, Zhang X, Peng C, Dang Q, Sun W, Lin L, Lin Y, Fan L, Lv D, Shao L, Chen Y, Qiu Y, Han L, Kong W, Li G, Wang K, Peng J, Lin B, Tong Z, Lu X, Wang L, Gao F, Feng J, Li Y, Ma X, Wang J, Wang S, Shen W, Wang C, Yan K, Lin Z, Jin C, Mao L, Liu J, Kushnareva Y, Kotoi O, Zhu Z, Royal M, Brunswick M, Ji H, Xu X, Lu H. Olgotrelvir as a Single-Agent Treatment of Nonhospitalized Patients with Covid-19. NEJM Evid. 2024 Jun;3(6):EVIDoa2400026. doi: 10.1056/EVIDoa2400026. Epub 2024 May 28.
Derived from this study: PubMed 38181791Mao L, Shaabani N, Zhang X, Jin C, Xu W, Argent C, Kushnareva Y, Powers C, Stegman K, Liu J, Xie H, Xu C, Bao Y, Xu L, Zhang Y, Yang H, Qian S, Hu Y, Shao J, Zhang C, Li T, Li Y, Liu N, Lin Z, Wang S, Wang C, Shen W, Lin Y, Shu D, Zhu Z, Kotoi O, Kerwin L, Han Q, Chumakova L, Teijaro J, Royal M, Brunswick M, Allen R, Ji H, Lu H, Xu X. Olgotrelvir, a dual inhibitor of SARS-CoV-2 Mpro and cathepsin L, as a standalone antiviral oral intervention candidate for COVID-19. Med. 2024 Jan 12;5(1):42-61.e23. doi: 10.1016/j.medj.2023.12.004. Epub 2024 Jan 4.
Individual participant dataSharing planned: No

Related trials for COVID-19

Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19

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.

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing STI-1558 in people with COVID-19, run by Zhejiang ACEA Pharmaceutical Co. Ltd. at 2 sites in China.

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 8 inclusion and 21 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: finished, as of the sponsor's last update on 14 May 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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 from the first dose to sustained recovery from 11 target symptoms of COVID-19. (time frame: Time from the first dose to the day when the score of each of the 11 target symptoms of COVID-19 is 0.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05716425, which also lists 2 linked publications.

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 14 May 2024.