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The Mechanism, Clinical Outcome and Therapeutic Intervention of Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive

Trial Profile

The Mechanism, Clinical Outcome and Therapeutic Intervention of Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 27 Apr 2020

At a glance

  • Drugs Favipiravir (Primary) ; Chloroquine diphosphate; Colistimethate sodium; Hydroxychloroquine; Umifenovir
  • Indications COVID 2019 infections
  • Focus Therapeutic Use
  • Most Recent Events

    • 22 Apr 2020 Status changed from not yet recruiting to recruiting.
    • 07 Apr 2020 New trial record

Trial Overview

Purpose

To investigate the mechanism, clinical outcome and therapeutic efficacy with favipiravir of Corona Virus Disease 2019 patients whose nucleic acids changed from negative to positive.

Primary Endpoints

Viral nucleic acid test negative conversion rate

description: Proportion of subjects who tested negative for nucleic acid from sputum or nasopharyngeal swabs for two consecutive times(sampling time at least 24 hours).
time_frame: 5 months

Other Endpoints

Clinical cure rate

description: Definition of clinical cure: The viral load of the respiratory specimen was negative for two consecutive times (the interval between the two tests was greater than or equal to one day), the lung image improved, and the body temperature returned to normal for more than 3 days, and the clinical manifestation improved.
time_frame: 5 months [1]

Diseases Treated

Indication Qualifiers Patient Segments
COVID 2019 infections treatment -

Subjects

  • Subject Type patients
  • Number

    Planned: 210

  • Sex male & female
  • Age Group 18-80 years; adult; elderly

Patient Inclusion Criteria

1. COVID-19 has been diagnosed, and the nucleic acid test of respiratory specimens such as sputum or nasopharyngeal swabs has been negative for two consecutive times after treatment (sampling time interval of at least 24 hours); 2. The nucleic acid test of specimens such as sputum, throat swabs, blood, feces and other specimens was positive for COVID-19 during screening visits; 3. Voluntarily participate in research and sign informed consent.

Patient Exclusion Criteria

1. Those allergic to fapilavir; 2. Pregnant or lactating women; 3. Unstable liver, kidney, and heart diseases; 4. History of mental disorders, substance abuse or dependence; 5. Researchers consider it inappropriate to participate in research; 6. Participating in other clinical research.

Trial Details

Identifiers

Identifier Owner
NCT04333589 ClinicalTrials.gov: US National Institutes of Health
2020research112 -

Trial Dates

  • Initiation Dates

    Planned : 01 Apr 2020

    Actual : 01 Apr 2020

  • Primary Completion Dates

    Planned : 01 Jun 2020

  • End Dates

    Planned : 15 Sep 2020

Other Details

  • Design multicentre; open; parallel; prospective; randomised
  • Phase of Trial Phase II
  • Location China
  • Focus Therapeutic Use

Interventions

Drugs Route Formulation
Chloroquine diphosphate
-
-
Colistimethate sodium
-
-
FavipiravirPrimary Drug Oral Tablet
Hydroxychloroquine
-
-
Umifenovir
-
-

Favipiravir group

On the 1st day, 1600mg each time, twice a day; from the 2nd to the 7th day, 600mg each time, twice a day. Oral administration, the maximum number of days taken is not more than 14 days. Drug: Favipiravir (On the 1st day, 1600mg each time, twice a day; from the 2nd to the 7th day, 600mg each time, twice a day. Oral administration, the maximum number of days taken is not more than 14 days.)

Regular treatment group

Treatments other than lopinavir and ritonavir, chloroquine phosphate, hydroxychloroquine sulfate, arbidol, and colomycin can be given.

Trial Centres

Investigators

Investigator Centre Name Trial Centre Country
Dingyu Zhang
13507117929
show details
Jinyintan Hospital of Wuhan China
Guiqiang Wang
13911405123
john131212@sina.com
show details
Peking University First Hospital
-
Hong Zhao
13810765943
zhaohong_pufh@bjmu.edu.cn
show details
-
Junhua Yu
13908688619
show details
Ezhou Central Hospital China
Sibin Zhang
13911992121
show details
Huoshenshan Hospital of Wuhan China
Xianfeng Han
13955881280
show details
The Second People's Hospital of Fuyang China
Xianxiang Chen
18971570937
show details
Wuhan Pulmonary Hospital China
Xinghuan Wang
18971387168
show details
Zhongnan Hospital of Wuhan University China
Xinsheng Chen
13972975677
show details
Ezhou Hospital of Traditional Chinese Medicine China
Yongping Chen
13505777281
show details
Wenzhou Medical University Affiliated First Hospital China

Centres

Centre Name Location Trial Centre Country
-
-
-
Ezhou Central Hospital Wuhan, Hubei China
Ezhou Hospital of Traditional Chinese Medicine Ezhou, Hubei China
Huoshenshan Hospital of Wuhan Wuhan, Hubei China
Jinyintan Hospital of Wuhan Wuhan, Hubei China
Peking University First Hospital
-
-
The Second People's Hospital of Fuyang Fuyang, Anhui China
Wenzhou Medical University Affiliated First Hospital Wenzhou, Zhejiang China
Wuhan Pulmonary Hospital Wuhan, Hubei China
Zhongnan Hospital of Wuhan University Wuhan, Hubei China

Trial History

Event Date Event Type Comment
27 Apr 2020 Other trial event Last checked against ClinicalTrials.gov record Updated 27 Apr 2020
22 Apr 2020 Status change - recruiting Status changed from not yet recruiting to recruiting. Updated 27 Apr 2020
07 Apr 2020 New trial record New trial record Updated 07 Apr 2020

References

  1. ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2016;.

    Available from: URL: http://clinicaltrials.gov
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