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

NCT05506176 | Completed Phase 2 DMC

• 1 other identifier: SIM0417-301
• Study Type: interventional
• Target: 1,208
• Locations: 1 country
• Sites: 35

Brief 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.

Conditions

COVID-19

Keywords

Mild to Moderate COVID-19

Outcome Measures

Primary Outcomes (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))

  Baseline through Day 29

Secondary Outcomes (19)

• Time to sustained recovery of 5 COVID-19 symptoms

  Baseline through Day 29

• Time to sustained alleviation of 7 COVID-19 symptoms

  Baseline through Day 29

• Time to sustained alleviation of 11 COVID-19 symptoms

  Baseline through Day 29

• Viral load

  Baseline through Day 14

• SARS-CoV-2 RNA

  Baseline through Day 14

Other Outcomes (9)

• Time to cessation of SARS-CoV-2 viral shedding (Viral load assessment)

  Baseline through Day 29

• Hospital and ICU stay

  Baseline through Week 12

• COVID-19 related medical visits

  Baseline through Day 29

Study Arms (2)

SIM-0417

EXPERIMENTAL

orally administrated SIM0417+ ritonavir

Drug: SIM0417

Placebo

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

SIM0417 DRUG

dose of 750 mg SIM0417 with 100 mg ritonavir.

Also known as: Simnotrelvir

SIM-0417

Placebo DRUG

Placebo (tablet)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Jiangsu Simcere Pharmaceutical Co., Ltd.: lead

Study Sites (35)

Hefei First People's Hospital

Hefei, Anhui, China

Location

Beijing Ditan Hospital Captial Medical University

Beijing, Beijing Municipality, China

Location

Chongqing Public Health Medical Center

Chongqing, Chongqing Municipality, China

Location

The First Affiliated Hospital of Xiamen University

Xiamen, Fujian, China

Location

Guangzhou Eighth People's Hospital Guangzhou Medical University

Guangzhou, Guangdong, China

Location

Maoming People's Hospital

Maoming, Guangdong, China

Location

Qingyuan People's Hospital

Qingyuan, Guangdong, China

Location

The Third People's Hospital of Shenzhen

Shenzhen, Guangdong, China

Location

Central People's Hospital of Zhanjiang

Zhanjiang, Guangdong, China

Location

The Fifth Affiliated Hospital Sun Yat-Sen University

Zhuhai, Guangdong, China

Location

GuiZhou Province People's Hospital

Guiyang, Guizhou, China

Location

Haikou people's Hospital

Haikou, Hainan, China

Location

Hainan Third People's Hospital

Sanya, Hainan, China

Location

Mudanjiang Kangan Hospital

Mudanjiang, Heilongjiang, China

Location

Wuhan Jinyintan Hospital

Wuhan, Hubei, China

Location

The First Hospital of Changsha

Changsha, Hunan, China

Location

The Second Hospital of Nanjing

Nanjing, Jiangsu, China

Location

ZhongDa Hospital SouthEast University

Nanjing, Jiangsu, China

Location

The Fifth People's Hospital of Suzhou

Suzhou, Jiangsu, China

Location

Taizhou People's Hospital

Taizhou, Jiangsu, China

Location

Wuxi No.5 People's Hospital

Wuxi, Jiangsu, China

Location

Xuzhou Infectious Disease Hospital

Xuzhou, Jiangsu, China

Location

Subei People's Hospital of Jiangsu province

Yangzhou, Jiangsu, China

Location

The Third People's Hospital of Zhenjiang

Zhenjiang, Jiangsu, China

Location

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Location

The Sixth People's Hospital of ShenYang

Shenyang, Liaoning, China

Location

Shandong Public Health Clinical Center

Jinan, Shandong, China

Location

Shanghai Public Health Clinical Center

Shanghai, Shanghai Municipality, China

Location

Public health clinical center of Chengdu

Chengdu, Sichuan, China

Location

Suining Central Hospital

Suining, Sichuan, China

Location

Tianjin first center hospital

Tianjin, Tianjin Municipality, China

Location

Affliated Hangzhou XiXi Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

Huzhou Central Hospital

Huzhou, Zhejiang, China

Location

HwaMei Hospital University of Chinese Academy of Sciences

Ningbo, Zhejiang, China

Location

Wenzhou Central Hospital

Wenzhou, Zhejiang, China

Location

Related Publications (2)

• 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.

  PMID: 40965470 DERIVED

• 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.

  PMID: 38231624 DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

SIM0417

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Chen Wang

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2022
• First Posted: August 18, 2022
• Study Start: August 19, 2022
• Primary Completion: January 23, 2023
• Study Completion: March 21, 2023
• Last Updated: May 6, 2023

Record last verified: 2023-05

Locations

CN (35)