The Mechanism, Clinical Outcome and Therapeutic Intervention of Corona Virus Disease 2019 Patients Whose Nucleic Acids Changed From Negative to Positive
Latest Information Update: 10 Apr 2022
At a glance
- Drugs Favipiravir (Primary) ; Chloroquine diphosphate; Colistimethate sodium; Hydroxychloroquine; Umifenovir
- Indications COVID 2019 infections
- Focus Therapeutic Use
- 01 Aug 2021 Primary endpoint (Viral nucleic acid test negative conversion rate) has been met according to the results published in the International Immunopharmacology
- 01 Aug 2021 Status changed from recruiting to completed.
- 01 Aug 2021 Results assessing efficacy and safety of favipiravir published in the International Immunopharmacology
Most Recent Events
Trial Overview
Outcome
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 [1]
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 [2]
Diseases Treated
| Indication | Qualifiers | Patient Segments |
|---|---|---|
| COVID 2019 infections | treatment | - |
Subjects
- Subject Type patients
-
Number
Planned: 210
Actual: 55
- 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 |
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|
-
|
| 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.
Results
Publications
-
Zhao H, Zhang C, Zhu Q, Chen X, Chen G, Sun W, et al. Favipiravir in the treatment of patients with SARS-CoV-2 RNA recurrent positive after discharge: A multicenter, open-label, randomized trial. Int-Immunopharmacol 2021;97107702.
PubMed | CrossRef Fulltext
Trial Centres
Investigators
| Investigator | Centre Name | Trial Centre Country |
|---|---|---|
|
Dingyu Zhang
13507117929
show details
|
Jinyintan Hospital of Wuhan | China |
|
Guiqiang Wang
13911405123
show details
john131212@sina.com |
Peking University First Hospital |
-
|
|
Hong Zhao
13810765943
show details
zhaohong_pufh@bjmu.edu.cn |
-
|
|
|
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 |
|---|---|---|
| 10 Apr 2022 | Other trial event | According to ClinicalTrials.gov, the recruitment status of this study is unknown because the information has not been verified recently (last verified Apr 2020). Updated 10 Apr 2022 |
| 10 Apr 2022 | Other trial event | Last checked against ClinicalTrials.gov record Updated 10 Apr 2022 |
| 01 Aug 2021 | Endpoint met | Primary endpoint (Viral nucleic acid test negative conversion rate) has been met according to the results published in the International Immunopharmacology Updated 07 Sep 2021 |
| 01 Aug 2021 | Status change - completed | Status changed from recruiting to completed. Updated 07 Sep 2021 |
| 01 Aug 2021 | Results | Results assessing efficacy and safety of favipiravir published in the International Immunopharmacology Updated 07 Sep 2021 |
| 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
-
Zhao H, Zhang C, Zhu Q, Chen X, Chen G, Sun W, et al. Favipiravir in the treatment of patients with SARS-CoV-2 RNA recurrent positive after discharge: A multicenter, open-label, randomized trial. Int-Immunopharmacol 2021;97107702.
PubMed | CrossRef Fulltext -
ClinicalTrials.gov: US National Institutes of Health. Trial-Reg 2023;.
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