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Trial record 1 of 1 for:    sildenafil | COVID-19
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A Pilot Study of Sildenafil in COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Brief Summary:
Observe the efficacy and safety of G1(Sildenafil citrate tablets) in patients with COVID-19 under clinical actual diagnosis and treatment conditions

Condition or disease Intervention/treatment Phase
COVID-19 Drug: Sildenafil citrate tablets Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of Sildenafi in the Treatment of COVID-19
Actual Study Start Date : February 9, 2020
Actual Primary Completion Date : March 1, 2020
Estimated Study Completion Date : November 9, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sildenafil citrate tablets Drug: Sildenafil citrate tablets
0.1g/day for 14 days




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Rate of no fever [ Time Frame: 14 days ]
  2. Rate of respiratory symptom remission [ Time Frame: 14 days ]
  3. Rate of lung imaging recovery [ Time Frame: 14 days ]
  4. Rate of C-reactive protein (CRP) recovery [ Time Frame: 14 days ]
  5. Rate of Biochemical criterion (CK, ALT, Mb) recovery [ Time Frame: 14 days ]
  6. Rate of undetectable viral RNA (continuous twice) [ Time Frame: 14 days ]
  7. 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.

  8. Rate of adverse event [ Time Frame: 14 days ]
    All adverse events will be coded and described using the International Medical Terms Dictionary (MedDRA).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04304313


Contacts
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Contact: Qing Ning, Professor +8613971521450 qning@vip.sina.com
Contact: Meifang Han, Professor +8613986093605 mfhan@foxmail.com

Locations
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China, Hubei
Department and Institute of Infectious Disease Recruiting
Wuhan, Hubei, China, 430030
Contact: Qin Ning, professor       qning@vip.sina.com   
Contact: Meifang Han, professor       mfhan@foxmail.com   
Sponsors and Collaborators
Tongji Hospital
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Responsible Party: Qin Ning, Professor, Tongji Hospital
ClinicalTrials.gov Identifier: NCT04304313    
Other Study ID Numbers: GST-G1
First Posted: March 11, 2020    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sildenafil Citrate
Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Urological Agents