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COVID-19Phase 2/3NCT05506176

A Clinical Study to Evaluate the Efficacy and Safety of SIM0417 Orally Co-Administered With Ritonavir in Symptomatic Adult Participants With Mild to Moderate COVID-19

A Phase 2/3 study testing SIM0417 in people with COVID-19, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 35 sites in China.

Completed

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

Official record
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Trial summary

This Phase Ⅱ/Ⅲ study is to evaluate whether or not there is a difference in time recovery of COVID-19 signs and symptoms through Day 29 between SIM0417/ritonavir and placebo. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COVID-19
What is being tested?
SIM0417
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,208 participants
Where
35 sitesChina
Study dates
19 Aug 2022to 21 Mar 2023
Phase
Phase 2/3
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

  • Participants ≥18 years of age (or the minimum country-specific age of consent if >18) at the time of signing the informed consent/assent form.
  • Initial positive SARS-CoV-2 tested by RT-PCR or rapid antigen test within 5 days (120 h) prior to the first dose of study drug collected from any respiratory tract specimen (e.g., oropharyngeal, NP or nasal swab, or saliva).
  • Initial onset of signs/symptoms attributable to COVID-19 within 3 days prior to the day of the first dose of study drug. The onset time of symptoms was defined as the time when body temperature first rose; or the onset of any of these COVID-19 symptoms.
  • At least one of the following symptoms of COVID-19 present within 24 hours prior to the first dose of study drug and meeting severity.
  • Has mild or moderate COVID-19.
  • Participants agree to take highly effective contraceptive measures from signing the informed consent to at least 1 month after the last dose of study intervention.
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Willing and able to provide written informed consent, or with a legal representative who can provide informed consent.

Who cannot join

  • Urgent or expected need for nasal high-flow oxygen therapy or positive pressure ventilation, invasive mechanical ventilation or Extracorporeal membrane oxygenation(ECMO).
  • Known medical history of active liver disease (other than nonalcoholic hepatic steatosis), including acute or chronic active hepatitis B or C infection, primary biliary cirrhosis, Child-Pugh Class B or C, or acute liver failure.
  • Receiving dialysis or have known moderate to severe renal impairment (ie, eGFR <45 mL/min/1.73 m2 within 6 months of the screening visit, using the serum creatinine-based CKD-EPI formula).
  • Compromised immune system (including patients receiving long-term immunosuppressant therapy, or those with progressed or relapsed cancer or human immunodeficiency virus [HIV] infection).
  • Moderate to severe congestive heart failure (New York Heart Association class III or IV) within 6 months prior to Screening, recent (within the past 6 months prior to Screening) cerebrovascular accident, myocardial infarction, coronary artery stenting, or uncontrolled hypertension (defined as documented systolic blood pressure > 160 mmHg or diastolic blood pressure > 100 mmHg).
  • Acute episode of chronic respiratory diseases, including bronchial asthma, chronic obstructive pulmonary disease.
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  • Suspected or confirmed concurrent active systemic infection other than COVID-19 (eg, co-infected with influenza) that may interfere with the evaluation of response to the study intervention.
  • Any comorbidity requiring surgery within 14 days prior to study entry, or that is considered life-threatening within 30 days prior to study entry, as determined by the investigator.
  • Has hypersensitivity or other contraindication to any of the components of the study interventions.
  • Other medical or psychiatric conditions including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
  • Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate ≥30 per minute, heart rate ≥125 per minute, oxygen saturation (SpO2) of ≤93% on room air or the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) <300 obtained at rest within 24 hours prior to randomization.
  • Treatment with antivirals against SARS-CoV-2 within 14 days prior to the first dose of randomization.
  • Current or expected use of any medications or substances that are highly dependent on CYP3A4 for clearance and for which elevated plasma concentrations may be associated with serious and/or life-threatening events during study treatment and for 4 days after the last dose of study drug (refer to Appendix 6).
  • Concomitant use of any medications or substances that are strong inducers of CYP3A4 are prohibited within 21 days prior to randomization and during study treatment (refer to Appendix 6).
  • Has received (within the past 30 days or 5 × drug half-life prior to randomization, which is longer) or is expected to receive COVID-19 monoclonal antibody or convalescent COVID-19 plasma during study treatment.
  • Systemic glucocorticoid therapy (prednisone ≥ 20 mg/day or equivalent doses of other steroids) for at least 14 consecutive days within 30 days prior to randomization.
  • Has received any SARS-CoV-2 vaccine within 3 months prior to randomization.
  • Participating in another interventional clinical study with an investigational compound or device, including those for COVID-19.
  • Previous administration with any investigational drug or vaccine within 30 days (or as determined by the local requirement) or 5 half-lives (whichever is longer) prior to randomization.
  • Known prior participation in this trial or other trial involving SIM0417.
  • Women who are breastfeeding or have a positive pregnancy test in the pre-dose examinations. The following female patients who have documentation of either a or b below do not need to undergo a pregnancy test in the pre-dose examinations:
  • Postmenopausal women (defined as cessation of regular menstrual periods for 12 months or more, and confirmed by a follicle-stimulating hormone test if <60 years old)
  • Women who are surgically sterile by hysterectomy, bilateral oophorectomy, or tubal ligation
  • Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments.
  • For subjects who have conditional ECG at screening only:
  • Clinically relevant or significant electrocardiographic abnormalities (e.g., second-degree type II AV block, left bundle branch block, etc.), including electrocardiographic QT interval corrected for heart rate using Fridericia 's correction formula (QTcF = QT/(RR0.33)) > 450 ms (males) or > 470 ms (females).

Trial locations and contacts

35 sites in 1 country.

35 sites in 1 country

China35 sites

  • Beijing Ditan Hospital Captial Medical University

    Beijing, Beijing Municipality

  • The First Hospital of Changsha

    Changsha, Hunan

  • Public health clinical center of Chengdu

    Chengdu, Sichuan

  • Chongqing Public Health Medical Center

    Chongqing, Chongqing Municipality

  • Guangzhou Eighth People's Hospital Guangzhou Medical University

    Guangzhou, Guangdong

  • GuiZhou Province People's Hospital

    Guiyang, Guizhou

  • Haikou people's Hospital

    Haikou, Hainan

  • Affliated Hangzhou XiXi Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Hefei First People's Hospital

    Hefei, Anhui

  • Huzhou Central Hospital

    Huzhou, Zhejiang

  • Shandong Public Health Clinical Center

    Jinan, Shandong

  • Maoming People's Hospital

    Maoming, Guangdong

  • Mudanjiang Kangan Hospital

    Mudanjiang, Heilongjiang

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi

  • The Second Hospital of Nanjing

    Nanjing, Jiangsu

  • ZhongDa Hospital SouthEast University

    Nanjing, Jiangsu

  • HwaMei Hospital University of Chinese Academy of Sciences

    Ningbo, Zhejiang

  • Qingyuan People's Hospital

    Qingyuan, Guangdong

  • Hainan Third People's Hospital

    Sanya, Hainan

  • Shanghai Public Health Clinical Center

    Shanghai, Shanghai Municipality

  • The Sixth People's Hospital of ShenYang

    Shenyang, Liaoning

  • The Third People's Hospital of Shenzhen

    Shenzhen, Guangdong

  • Suining Central Hospital

    Suining, Sichuan

  • The Fifth People's Hospital of Suzhou

    Suzhou, Jiangsu

  • Taizhou People's Hospital

    Taizhou, Jiangsu

  • Tianjin first center hospital

    Tianjin, Tianjin Municipality

  • Wenzhou Central Hospital

    Wenzhou, Zhejiang

  • Wuhan Jinyintan Hospital

    Wuhan, Hubei

  • Wuxi No.5 People's Hospital

    Wuxi, Jiangsu

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • Xuzhou Infectious Disease Hospital

    Xuzhou, Jiangsu

  • Subei People's Hospital of Jiangsu province

    Yangzhou, Jiangsu

  • Central People's Hospital of Zhanjiang

    Zhanjiang, Guangdong

  • The Third People's Hospital of Zhenjiang

    Zhenjiang, Jiangsu

  • The Fifth Affiliated Hospital Sun Yat-Sen University

    Zhuhai, Guangdong

Other trials in China

About this study

Official title: A Multicenter, Randomized, Double-blind, Phase Ⅱ/Ⅲ Clinical Study to Evaluate the Efficacy and Safety of SIM0417 Orally Co-Administered With Ritonavir in Symptomatic Adult Participants With Mild to Moderate COVID-19

This Phase Ⅱ/Ⅲ study is to evaluate whether or not there is a difference in time recovery of COVID-19 signs and symptoms through Day 29 between SIM0417/ritonavir and placebo.

Read the detailed description

The efficacy, safety, and tolerability of SIM0417/ritonavir compared to placebo will be investigated. The exposure to SIM0417 in this population will also be investigated.

Conditions
COVID-19
Being tested
SIM0417, Placebo
Keywords
Mild to Moderate COVID-19
Medical subject headings
COVID-19

What participants receive

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

  • SIM0417Drug

    Also called Simnotrelvir

    dose of 750 mg SIM0417 with 100 mg ritonavir.

  • PlaceboDrug

    Placebo (tablet)

Study groups in NCT05506176
Study groupRoleWhat they receive
SIM-0417Experimentalorally administrated SIM0417+ ritonavir
Receives: Drug: SIM0417
PlaceboPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

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

  1. Time to sustained recovery of 11 COVID-19 symptoms

    The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 (absence or return to the status before the onset) for two consecutive days.(Participant-completed study diary (COVID-19 symptoms and signs, and global impression questions))

    Measured: Baseline through Day 29

Secondary outcomes (19)

  1. Time to sustained recovery of 5 COVID-19 symptoms

    The time from the start of treatment to the time when 5 COVID-19 symptoms get scores of 0 (absence or return to the status before the onset) or 1 (mild) for two consecutive days.

    Measured: Baseline through Day 29

  2. Time to sustained alleviation of 7 COVID-19 symptoms

    The time from the start of treatment to the time when 7 COVID-19 symptoms get scores of 0 (absence or return to the status before the onset) or 1 (mild) for two consecutive days.

    Measured: Baseline through Day 29

  3. Time to sustained alleviation of 11 COVID-19 symptoms

    The time from the start of treatment to the time when 11 COVID-19 symptoms get scores of 0 (absence or return to the status before the onset) or 1 (mild) for two consecutive days.

    Measured: Baseline through Day 29

  4. Viral load

    Changes of viral load compared to the baseline.

    Measured: Baseline through Day 14

  5. SARS-CoV-2 RNA

    Proportion of participants with SARS-CoV-2 RNA below the threshold.

    Measured: Baseline through Day 14

  6. Severe COVID-19 disease

    Incidence of disease progression by COVID-19 severity.

    Measured: Baseline through Day 29

  7. Hospitalization or death

    Proportion of participants with hospitalization or death from any cause.

    Measured: Baseline through Day 29

  8. ICU stay

    Proportion of participants admitted into ICU.

    Measured: Baseline through Day 29

  9. Requiring supplemental oxygen

    Proportion of participants requiring supplemental oxygen (low-flow nasal cannula, simple face mask).

    Measured: Baseline through Day 29

  10. Requiring mechanical ventilation/ECMO

    Proportion of participants requiring mechanical ventilation/ECMO.

    Measured: Baseline through Day 29

  11. Death (all cause)

    Proportion of participants with death (all cause).

    Measured: Baseline through Week 12

  12. WHO clinical progression scale score

    Change from baseline in WHO clinical progression scale score.

    Measured: Baseline through Day 29

  13. Time to sustained recovery of each targeted COVID-19 symptom

    The time from the start of treatment to the time when each targeted COVID-19 symptom gets scores of 0 (absence or return to the status before the onset) for two consecutive days.

    Measured: Baseline through Day 29

  14. Proportion of sustained recovery of COVID-19 symptoms

    Proportion of patients whose symptoms has been sustainedly recovered.

    Measured: Baseline through Day 29

  15. Severity of COVID-19 symptoms

    Severity of each COVID-19 symptom.

    Measured: Baseline through Day 29

  16. Composite symptom score

    Change from baseline in composite symptom score.

    Measured: Baseline through Day 29

  17. Treatment-Related Adverse Events (TEAEs)

    Incidence of Treatment-Related Adverse Events (TEAEs).

    Measured: Baseline through Day 29

  18. Serious Adverse Events (SAEs)

    Incidence of Serious Adverse Events (SAEs) Assessed.

    Measured: Baseline through Week 12

  19. The plasma concentration of SIM0417

    The trough concentrations of SIM0417.

    Measured: Baseline through Day 5

Timeline

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

  1. First posted18 Aug 2022
  2. Study start19 Aug 2022
  3. Primary completion23 Jan 2023
  4. Study completion21 Mar 2023

Resources

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,208 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05506176
Sponsor's protocol ID
SIM0417-301
Status last verified
May 2023
First submitted
12 Aug 2022
Last updated
6 May 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Yao B-F, Yang Y, Xu S-S, Tang B-H, Chen J, Guo Z-J, Hu H-L, Zhang W, Fu S-M, Zhang X-F, Hao G-X, Yang X-M, Song L-L, Ye P-P, Liu L, Zhu S-W, Zheng Y, Zhao W. Model-informed drug development in public health emergency of international concern: accelerating marketing authorization of simnotrelvir. Antimicrob Agents Chemother. 2025 Nov 5;69(11):e0061425. doi: 10.1128/aac.00614-25. Epub 2025 Sep 18.

    PubMed 40965470

  • Cao B, Wang Y, Lu H, Huang C, Yang Y, Shang L, Chen Z, Jiang R, Liu Y, Lin L, Peng P, Wang F, Gong F, Hu H, Cheng C, Yao X, Ye X, Zhou H, Shen Y, Liu C, Wang C, Yi Z, Hu B, Xu J, Gu X, Shen J, Xu Y, Zhang L, Fan J, Tang R, Wang C. Oral Simnotrelvir for Adult Patients with Mild-to-Moderate Covid-19. N Engl J Med. 2024 Jan 18;390(3):230-241. doi: 10.1056/NEJMoa2301425.

    PubMed 38231624

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing SIM0417 in people with COVID-19, run by Jiangsu Simcere Pharmaceutical Co., Ltd. at 35 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 26 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 6 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 to sustained recovery of 11 COVID-19 symptoms (time frame: Baseline through Day 29). 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 NCT05506176, 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 6 May 2023.

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