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A Pilot Study of Sildenafil in COVID-19

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ClinicalTrials.gov Identifier: NCT04304313
Recruitment Status : Recruiting
First Posted : March 11, 2020
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Qin Ning, Tongji Hospital

Tracking Information
First Submitted Date  ICMJE February 14, 2020
First Posted Date  ICMJE March 11, 2020
Last Update Posted Date March 17, 2020
Actual Study Start Date  ICMJE February 9, 2020
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
  • Rate of disease remission [ Time Frame: 14 days ]
    1. fever,cough and other symptoms relieved with improved lung CT;
    2. SPO2>93% or PaO2/FiO2 >300mmHg without oxygen inhalation.
  • Rate of entering the critical stage [ Time Frame: 14 days ]
    Comply with any of the followings:
    1. Respiratory failure occurs and requires mechanical ventilation;
    2. Shock;
    3. Patients combined with other organ failure need ICU monitoring and treatment.
  • Time of entering the critical stage [ Time Frame: 14 days ]
    Comply with any of the followings:
    1. Respiratory failure occurs and requires mechanical ventilation;
    2. Shock;
    3. Patients combined with other organ failure need ICU monitoring and treatment.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 10, 2020)
  • Rate of no fever [ Time Frame: 14 days ]
  • Rate of respiratory symptom remission [ Time Frame: 14 days ]
  • Rate of lung imaging recovery [ Time Frame: 14 days ]
  • Rate of C-reactive protein (CRP) recovery [ Time Frame: 14 days ]
  • Rate of Biochemical criterion (CK, ALT, Mb) recovery [ Time Frame: 14 days ]
  • Rate of undetectable viral RNA (continuous twice) [ Time Frame: 14 days ]
  • Time for hospitalization [ Time Frame: 14 days ]
    From the date of enrollment to the time when the subject is released from the hospital or transferred to the corresponding department for treatment of other diseases according to the condition.
  • Rate of adverse event [ Time Frame: 14 days ]
    All adverse events will be coded and described using the International Medical Terms Dictionary (MedDRA).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of Sildenafil in COVID-19
Official Title  ICMJE A Pilot Study of Sildenafi in the Treatment of COVID-19
Brief Summary Observe the efficacy and safety of G1(Sildenafil citrate tablets) in patients with COVID-19 under clinical actual diagnosis and treatment conditions
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE COVID-19
Intervention  ICMJE Drug: Sildenafil citrate tablets
0.1g/day for 14 days
Study Arms  ICMJE Experimental: Sildenafil citrate tablets
Intervention: Drug: Sildenafil citrate tablets
Publications * Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifirò G. Challenges for Drug Repurposing in the COVID-19 Pandemic Era. Front Pharmacol. 2020 Nov 6;11:588654. doi: 10.3389/fphar.2020.588654. eCollection 2020. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 10, 2020)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 9, 2020
Actual Primary Completion Date March 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Patients diagnosed as COVID-19:

    1. mild patient: fever,respiratory and other symptoms, the manifestation of pneumonia can be seen on imaging.
    2. severe patients: meet the definition of severe pneumonia(comply with any of the followings): Shortness of breath,RR≥30 bpm;In a resting state:SPO2≤93%;PaO2/FiO2≤300mmHg.
  2. Age≥18 years old,unlimited gender.
  3. Patients who cannot stop the following drugs during the trial:erythromycin or strong inhibitors of CYP3A4 (such as saquinavir,ketoconazole,itraconazole),nonspecific inhibitors of CYP (such as cimetidine),HIV protease inhibitors (such as ritonavir).
  4. Willing to participate in this study,signed Informed Consent and willing to participate in regular follow-up during the study.

Exclusion Criteria:

  1. Suffer from severe cognitive impairment or mental illness.
  2. Pregnant and lactating women.
  3. Patients taking nitric oxide drugs and nitrates in any dosage form.
  4. Patients with malignant tumors;AMI, stroke or life-threatening arrhythmias within 6 months;hereditary pigmented retinitis;heart failure or unstable angina pectoris of coronary heart disease;patients with severe hypotension and hypertension.
  5. Patients who are allergic to the study drug or the researcher believes it is not appropriate.
  6. Participate in other clinical studies at the same time.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Qing Ning, Professor +8613971521450 qning@vip.sina.com
Contact: Meifang Han, Professor +8613986093605 mfhan@foxmail.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04304313
Other Study ID Numbers  ICMJE GST-G1
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Qin Ning, Tongji Hospital
Study Sponsor  ICMJE Tongji Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tongji Hospital
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP