NCT04304313

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for phase_3 covid19

Timeline
Completed

Started Feb 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 9, 2020

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2020

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 11, 2020

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

21 days

First QC Date

February 14, 2020

Last Update Submit

March 14, 2020

Conditions

COVID-19

Outcome Measures

Primary Outcomes (3)

  • Rate of disease remission

    1. fever,cough and other symptoms relieved with improved lung CT; 2. SPO2\>93% or PaO2/FiO2 \>300mmHg without oxygen inhalation.

    14 days

  • Rate of entering the critical stage

    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.

    14 days

  • Time of entering the critical stage

    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.

    14 days

Secondary Outcomes (8)

  • Rate of no fever

    14 days

  • Rate of respiratory symptom remission

    14 days

  • Rate of lung imaging recovery

    14 days

  • Rate of C-reactive protein (CRP) recovery

    14 days

  • Rate of Biochemical criterion (CK, ALT, Mb) recovery

    14 days

  • +3 more secondary outcomes

Study Arms (1)

Sildenafil citrate tablets

EXPERIMENTAL
Drug: Sildenafil citrate tablets

Interventions

Sildenafil citrate tabletsDRUG

0.1g/day for 14 days

Sildenafil citrate tablets

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed as COVID-19:
  • mild patient: fever,respiratory and other symptoms, the manifestation of pneumonia can be seen on imaging.
  • 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.
  • Age≥18 years old,unlimited gender.
  • 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).
  • Willing to participate in this study,signed Informed Consent and willing to participate in regular follow-up during the study.

You may not qualify if:

  • Suffer from severe cognitive impairment or mental illness.
  • Pregnant and lactating women.
  • Patients taking nitric oxide drugs and nitrates in any dosage form.
  • 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.
  • Patients who are allergic to the study drug or the researcher believes it is not appropriate.
  • Participate in other clinical studies at the same time.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department and Institute of Infectious Disease

Wuhan, Hubei, 430030, China

RECRUITING

Related Publications (1)

  • Sultana J, Crisafulli S, Gabbay F, Lynn E, Shakir S, Trifiro 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.

    PMID: 33240091DERIVED

MeSH Terms

Conditions

COVID-19

Interventions

Sildenafil Citrate

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

SulfonamidesAmidesOrganic ChemicalsSulfonesSulfur CompoundsPiperazinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Central Study Contacts

Qing Ning, Professor

CONTACT

+8613971521450qning@vip.sina.com

Meifang Han, Professor

CONTACT

+8613986093605mfhan@foxmail.com

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 14, 2020

First Posted

March 11, 2020

Study Start

February 9, 2020

Primary Completion

March 1, 2020

Study Completion

November 9, 2020

Last Updated

March 17, 2020

Record last verified: 2020-03

Locations

CN(1)