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| Name | Class |
|---|---|
| Medicines for Malaria Venture | OTHER |
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This exploratory study is a randomized, single center, open label study of four different experimental treatment arms versus standard of care for the treatment of SARS-CoV-2 infection in symptomatic outpatients with mild disease at the time of enrollment.
This phase 2, exploratory study will be an adaptive, randomized, open label, trial for treatment of individuals in an outpatient settings with mild SARS-CoV-2 infection. The primary outcome is focused on the evaluation of efficacy of the proposed experimental drugs in reducing upper respiratory viral shedding, defined as viral clearance (i.e., negative swab) on Day 7. Key secondary outcomes focus on other measures of viral shedding, safety evaluation, progression to LRTI (defined by resting blood oxygen saturation level [SpO2] <93% sustained for two readings two hours apart and presence of subjective dyspnoea or cough), disease severity, clinical resolution rate, and cumulative incidence of hospitalization or mortality at Day 28.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paracetamol (SOC) | Placebo Comparator | 500 mg oral tablets. Two tablets taken at 6-hour intervals as needed, in all treatment arms (in addition to any investigative treatment) |
|
| Artesunate-amodiaquine (ASAQ) | Experimental | Fixed dose combination tablets containing 100 mg artesunate and 270 mg amodiaquine. Participants received two tablets once daily for 3 days |
|
| Pyronaridine-artesunate (PA) | Experimental | Fixed dose combination tablets containing 180 mg pyronaridine and 60 mg artesunate, given once daily for 3 days. Participants weighing 45 to <65 kg received 3 tablets per dose, those ≥65 kg received 4 tablets per dose |
|
| Favipiravir plus nitazoxanide (FPV-NTZ) | Experimental | Free combination of favipiravir 200 mg and 400 mg tablets and nitazoxanide 500 mg tablets. Participants received favipiravir as a loading dose of 1600 mg twice daily for 1 day followed by 600 mg twice daily for 6 days, and nitazoxanide 1000 mg twice daily, with food, for 7 days |
|
| SOC plus Sofosbuvir/daclatasvir | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paracetamol | Drug | SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of SARS-CoV-2 Clearance | Day 7 |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of SARS-CoV-2 Clearance | Day 3, 10, 14, 21, 28 | |
| Time to Clearance of Nasal SARS-CoV-2 | Day 0, 3, 7, 10, 14, 21, 28 | |
| Estimated Viral Load of SARS-CoV-2 Detected by Quantitative RT-PCR |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Pregnant or lactating women.
Known hypersensitivity or specific contraindications to the use of any of the active drugs in the treatment arms, or similar compounds.
Signs of respiratory distress prior to randomization, including:
Resting pulse rate ≥120 beats/min.
High likelihood of hospitalization in the opinion of the attending clinician.
QTcF >470 msec for females, or >450 msec for males, at screening.
Serum potassium <3.5 mmol/L at screening.
History of clinically significant cardiovascular disease (including arrhythmias, QT-interval prolongation, torsades de pointes (TdP), history of coronary artery disease with graft or stent procedures/surgery, cardiac failure [class 2 or higher using the New York Heart Association functional classification]).
Known chronic kidney disease (Stage IV or receiving dialysis).
Known cirrhosis (Child-Pugh Class B or greater).
Known macular degeneration, or other known retinal diseases, or 4-aminoquinolone-induced visual impairment.
Currently receiving, or recently received (within 60 days prior to randomization) treatment with any of the drugs in the treatment arms.
Currently receiving, or recently received (within 30 days prior to randomization) treatment with any antimalarial drugs.
Currently on treatment with drugs with known arrhythmogenic potential, or those known to induce significant QT-interval prolongation or TdP, as detailed in Appendix 6.
Currently on treatment for tuberculosis (or on treatment with rifampicin for any other indication), or on treatment with a protease inhibitor-based antiretroviral regimen, or efavirenz, or carbamazepine.
Inability/unlikely to be in the study area for the duration of the 28 day follow-up period.
Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the safety of the volunteer or the objectives of the study. The Investigator should make this determination in consideration of the volunteer's medical history.
Personnel (e.g. investigator, sub-investigator, research assistant, pharmacist, study coordinator or anyone mentioned in the delegation log) directly involved in the conduct of the study.
Participant is judged by the Investigator to be at significant risk of failing to comply with the provisions of the protocol as to cause harm to self or seriously interfere with the validity of the study results.
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| Name | Affiliation | Role |
|---|---|---|
| Francois Venter, PhD | Ezintsha, Wits Reproductive Health & HIV Institute University of the Witwatersrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ezintsha, Wits Reproductive Health & HIV Institute University of the Witwatersrand | Johannesburg | South Africa |
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| ID | Title | Description |
|---|---|---|
| FG000 | Paracetamol (SOC) | Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed |
| FG001 | SOC Plus Artesunate-Amodiaquine | Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 17, 2020 | May 10, 2024 |
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Fixed dose combination tablets containing 400 mg sofosbuvir and 60 mg daclatasvir. Participants received 1 tablet once daily for 7 days
|
| Artesunate-amodiaquine | Drug | SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days |
|
|
| Pyronaridine-artesunate | Drug | SOC plus pyronaridine-artesunate (PA) Weight 45 to <65 kg: 3 tablets (540/180 mg pyronaridine/artesunate) daily for 3 days Weight ≥65 kg: 4 tablets (720/240 mg pyronaridine/artesunate) daily for 3 days |
|
|
| Favipiravir plus Nitazoxanide | Drug | SOC plus favipiravir plus nitazoxanide (FPV-NTZ) Favipiravir: 1600 mg 12-hourly for 1 day then 600 mg 12-hourly for 6 days Nitazoxanide: 2 tablets (1000 mg) 12-hourly for 7 days |
|
|
| Sofosbuvir/daclatasvir | Drug | SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days |
|
|
baseline and day14, Day 14 value minus baseline value |
| Day 14 |
| Poisson Regression for Proportion of Days With Fever After Randomization | Day 28 |
| Percentage of Days With Respiratory Symptoms After Randomization | "Percentage of total study days in which participants experienced respiratory symptoms until day 28. Percentage calculated as (No. of days with respiratory symptoms) ÷ (No. of days observation) x 100" | from randomization to end of study (until day 28) |
| FLU-PRO Plus Questionnaire Scores and FLU-PRO Plus Global Additional Daily Diary Items Over the First 14 Days | baseline and day 14, Day 14 value minus baseline value The FLU-PRO(inFLUenza Patient-Reported Outcome) Plus questionnaire was completed daily during the first 14 days, at Day 21 and at Day 28. From these items six domain scores for the body areas Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal, and Body/Systemic could be computed ranging from 0 (symptom free) to 4 (very severe symptoms). Total Score Range for FLU-PRO Plus
| 14 days |
| Serious Adverse Events | Day 28 |
| Adverse Events | Day 28 |
| Related Adverse Events | Day 28 |
| LRTI | Day 28 |
| Maximum Score on WHO Ordinal Scale for Clinical Improvement During Study Participation | Day 28 |
| Cumulative Incidence of Hospitalization | Day 28 |
| Days of Hospitalization | Total number of hospitalization days for hospitalized participants in each group | Day 28 |
| Cumulative Incidence of Mortality, Measured at Day 28 or Later if Participant is Hospitalized at the Time of Day 28 | at Day 28 or later if participant is hospitalized at the time of Day 28 for up to 2 months |
| FG002 | SOC Plus Favipiravir Plus Nitazoxanide | Favipiravir plus Nitazoxanide: SOC plus favipiravir plus nitazoxanide (FPV-NTZ) Favipiravir: 1600 mg 12-hourly for 1 day then 600 mg 12-hourly for 6 days Nitazoxanide: 2 tablets (1000 mg) 12-hourly for 7 days |
| FG003 | SOC Plus Pyronaridine-Artesunate | Pyronaridine-artesunate: SOC plus pyronaridine-artesunate (PA) Weight 45 to <65 kg: 3 tablets (540/180 mg pyronaridine/artesunate) daily for 3 days Weight ≥65 kg: 4 tablets (720/240 mg pyronaridine/artesunate) daily for 3 days |
| FG004 | SOC Plus Sofosbuvir/Daclatasvir | Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Paracetamol (SOC) | Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed |
| BG001 | ASAQ | SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days |
| BG002 | PA(Pyronaridine-Artesunate) | SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: SOC plus pyronaridine-artesunate (PA) Weight 45 to <65 kg: 3 tablets (540/180 mg pyronaridine/artesunate) daily for 3 days Weight ≥65 kg: 4 tablets (720/240 mg pyronaridine/artesunate) daily for 3 days |
| BG003 | FPV-NTZ | SOC plus Favipiravir plus Nitazoxanide Favipiravir plus Nitazoxanide: SOC plus favipiravir plus nitazoxanide (FPV-NTZ) Favipiravir: 1600 mg 12-hourly for 1 day then 600 mg 12-hourly for 6 days Nitazoxanide: 2 tablets (1000 mg) 12-hourly for 7 days |
| BG004 | SOF/DCV | SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days |
| BG005 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment | Count of Participants | Participants |
| |||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment | Count of Participants | Participants |
| |||||||||||||||
| Race (NIH/OMB) | Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment | Count of Participants | Participants | No |
| ||||||||||||||
| Region of Enrollment | Percentages are based on the number participants in the mITT analysis set Participants in all investigational treatment arms received SoC in addition to the respective experimental treatment | Count of Participants | Participants | No |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of SARS-CoV-2 Clearance | Posted | Number | percentage of paticaipants | Day 7 |
|
|
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Incidence of SARS-CoV-2 Clearance | Posted | Number | percentage of paticaipants | Day 3, 10, 14, 21, 28 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Time to Clearance of Nasal SARS-CoV-2 | Posted | Median | 95% Confidence Interval | Time(day) | Day 0, 3, 7, 10, 14, 21, 28 |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Estimated Viral Load of SARS-CoV-2 Detected by Quantitative RT-PCR | baseline and day14, Day 14 value minus baseline value | Posted | Mean | Standard Deviation | Log₁₀ copies/mL | Day 14 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Poisson Regression for Proportion of Days With Fever After Randomization | Posted | Number | proportion | Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Days With Respiratory Symptoms After Randomization | "Percentage of total study days in which participants experienced respiratory symptoms until day 28. Percentage calculated as (No. of days with respiratory symptoms) ÷ (No. of days observation) x 100" | Posted | Mean | 95% Confidence Interval | Percentage (%) | from randomization to end of study (until day 28) |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | FLU-PRO Plus Questionnaire Scores and FLU-PRO Plus Global Additional Daily Diary Items Over the First 14 Days | baseline and day 14, Day 14 value minus baseline value The FLU-PRO(inFLUenza Patient-Reported Outcome) Plus questionnaire was completed daily during the first 14 days, at Day 21 and at Day 28. From these items six domain scores for the body areas Nose, Throat, Eyes, Chest/Respiratory, Gastrointestinal, and Body/Systemic could be computed ranging from 0 (symptom free) to 4 (very severe symptoms). Total Score Range for FLU-PRO Plus
| Posted | Median | Standard Deviation | score | 14 days |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Serious Adverse Events | Posted | Count of Participants | Participants | Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Adverse Events | Posted | Count of Participants | Participants | Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Related Adverse Events | Posted | Count of Participants | Participants | Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | LRTI | Posted | Count of Participants | Participants | Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Maximum Score on WHO Ordinal Scale for Clinical Improvement During Study Participation | Posted | Median | Standard Deviation | score | Day 28 |
| |||||||||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of Hospitalization | Posted | Count of Participants | Participants | Day 28 |
| ||||||||||||||||||||||||||||||||||||||||||
| Secondary | Days of Hospitalization | Total number of hospitalization days for hospitalized participants in each group | Posted | Mean | Standard Deviation | Days | Day 28 |
| ||||||||||||||||||||||||||||||||||||||||
| Secondary | Cumulative Incidence of Mortality, Measured at Day 28 or Later if Participant is Hospitalized at the Time of Day 28 | Posted | Count of Participants | Participants | at Day 28 or later if participant is hospitalized at the time of Day 28 for up to 2 months |
|
Day 28 and up to 3 months after end of study treatment
Adverse events and serious adverse events were collected from the start of treatment through Day 28 and up to 3 months after the end of the clinical trial. Each event was assessed for severity, seriousness, and relationship to the investigational product.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SOC (Paracetamol) | Paracetamol (SOC) Standard of care (Paracetamol): SOC - 2 tablets (1000 mg) to be taken 6-hourly as needed | 0 | 39 | 0 | 39 | 14 | 39 |
| EG001 | ASAQ | SOC plus Artesunate-Amodiaquine Artesunate-amodiaquine: SOC plus artesunate-amodiaquine (ASAQ) - 2 tablets (200/540 mg artesunate/amodiaquine) daily for 3 days | 0 | 39 | 0 | 39 | 18 | 39 |
| EG002 | PA(Pyronaridine-Artesunate) | SOC plus Pyronaridine-Artesunate Pyronaridine-artesunate: SOC plus pyronaridine-artesunate (PA) Weight 45 to <65 kg: 3 tablets (540/180 mg pyronaridine/artesunate) daily for 3 days Weight ≥65 kg: 4 tablets (720/240 mg pyronaridine/artesunate) daily for 3 days | 0 | 38 | 0 | 38 | 21 | 38 |
| EG003 | FPV-NTZ | SOC plus Favipiravir plus Nitazoxanide Favipiravir plus Nitazoxanide: SOC plus favipiravir plus nitazoxanide (FPV-NTZ) Favipiravir: 1600 mg 12-hourly for 1 day then 600 mg 12-hourly for 6 days Nitazoxanide: 2 tablets (1000 mg) 12-hourly for 7 days | 0 | 36 | 1 | 36 | 31 | 36 |
| EG004 | SOF/DCV | SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days | 0 | 36 | 0 | 36 | 16 | 36 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pancytopenia | Blood and lymphatic system disorders | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| nausea | Gastrointestinal disorders | Systematic Assessment |
| ||
| diarrhea | Gastrointestinal disorders | Systematic Assessment |
| ||
| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
| ||
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
| ||
| Constipation | Gastrointestinal disorders | Systematic Assessment |
| ||
| Mouth ulceration | Gastrointestinal disorders | Systematic Assessment |
| ||
| Haemorrhoids | Gastrointestinal disorders | Systematic Assessment |
| ||
| Upper respiratory tract infection | Infections and infestations | Systematic Assessment |
| ||
| Vulvovaginal candidiasis | Infections and infestations | Systematic Assessment |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Muscle spasms | Musculoskeletal and connective tissue disorders | Systematic Assessment |
| ||
| Dizziness | Nervous system disorders | Systematic Assessment |
| ||
| Headache | Nervous system disorders | Systematic Assessment |
| ||
| Insomnia | Psychiatric disorders | Systematic Assessment |
| ||
| Chromaturia | Renal and urinary disorders | Systematic Assessment |
| ||
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
| ||
| Chest discomfort | General disorders | Systematic Assessment |
| ||
| Chest pain | General disorders | Non-systematic Assessment |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shin Poong Pharm. Co., Ltd. | Shin Poong Pharm. Co., Ltd. | 82-2-2189-3478 | bwon@shinpoong.co.kr |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 1, 2022 | Nov 20, 2024 | SAP_001.pdf |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000082 | Acetaminophen |
| C515299 | amodiaquine, artesunate drug combination |
| C000712628 | pyronaridine tetraphosphate, artesunate drug combination |
| C462182 | favipiravir |
| C041747 | nitazoxanide |
| D000069474 | Sofosbuvir |
| C549273 | daclatasvir |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Coloured |
|
| White |
|
| Asian or Indian |
|
| Other |
|
| OG004 |
| Arm E |
SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days |
|
|
| OG004 |
| Arm E |
SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days |
|
|
| OG004 | Arm E | SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days |
|
|
| OG004 |
| Arm E |
SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days |
|
|
| OG004 | Arm E | SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days |
|
|
| OG003 | Arm D | SOC plus Favipiravir plus Nitazoxanide Favipiravir plus Nitazoxanide: SOC plus favipiravir plus nitazoxanide (FPV-NTZ) Favipiravir: 1600 mg 12-hourly for 1 day then 600 mg 12-hourly for 6 days Nitazoxanide: 2 tablets (1000 mg) 12-hourly for 7 days |
| OG004 | Arm E | SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days |
|
|
| Arm E |
SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days |
|
|
| Arm E |
SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days |
|
|
| Arm E |
SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days |
|
|
| Arm E |
SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days |
|
|
| OG004 | Arm E | SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days |
|
|
| Arm E |
SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days |
|
|
| OG004 | Arm E | SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days |
|
|
| OG004 | Arm E | SOC plus Sofosbuvir/daclatasvir Sofosbuvir/daclatasvir: SOC plus sofosbuvir/daclatasvir (SOF/DCV) 1 tablet (400 mg/60 mg sofosbuvir/daclatasvir) daily for 7 days |
|
|