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Only one patient was enrolled, who who later withdrew the consent. They decided not to contunie the study.
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| Name | Class |
|---|---|
| Hungarian Ministry of Innovation and Technology | UNKNOWN |
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The aim of the study is to assess the safety and efficacy of Favipiravir HU when administered to SARS-Cov- 2 patients in order to offer a safe and effective treatment to SARS-Cov-2 infection during the pandemic. The study is not for registration purposes and is not part of a series of studies for registration of Favipiravir HU.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Favipiravir HU + SOC | Experimental | Favipiravir HU + SOC |
|
| Placebo HU + SOC | Placebo Comparator | Placebo HU + SOC |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Favipiravir HU 200 mg hard capsules | Drug | Drug substance: Favipiravir Dose: 200 mg Administration: oral Formulation: capsules |
|
| Measure | Description | Time Frame |
|---|---|---|
| PRIM1_ the percentage of virus copy number | The primary endpoint of the study is the percentage of virus copy number at Day6 compared to baseline. | 5 months |
| Measure | Description | Time Frame |
|---|---|---|
| SEC1_mortality rate | Overall mortality rate | 6 months |
| SEC2_respiratory failure | Proportion of patients with respiratory failure | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| KSEC1_Time to virus elimination | Number of days from treatment start to virus elimination | 5 months |
| KSEC2_severe stages of COVID-19 | Proportion of patients achieving more severe stages of COVID-19 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Szeged - Internal Medicine | Szeged | Hungary |
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| ID | Term |
|---|---|
| D006244 | Hardness |
| ID | Term |
|---|---|
| D055595 | Mechanical Phenomena |
| D055585 | Physical Phenomena |
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double-blinded
| Placebo HU | Drug | Name: Placebo clinical sample Drug substance: placebo Dose: - Administration: oral Formulation: capsules |
|
| SEC3_ intensive care | Proportion of patients with need for intensive care | 6 months |
| SEC4_non-invasive respiratory support | Proportion of patients with need for non-invasive respiratory support | 6 months |
| SEC5_ invasive respiratory support | Proportion of patients with need for invasive respiratory support | 6 months |
| SEC6_ Acute Respiratory Distress Syndrome | Proportion of patients with Acute Respiratory Distress Syndrome | 6 months |
| 6 months |
| KSEC3_Time to recovery | Time to recovery in patients who have developed symptoms | 6 months |
| KSEC4_ adverse event | Number and proportion of patients with at least 1 adverse event related to study treatment | 6 months |