Covid 19 Research using Clinical Trials (Home Page)
placeboWiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (21)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug562 | Ibuprofen Wiki | 0.33 |
| drug717 | MuscleSound Ultrasound Wiki | 0.33 |
| drug1295 | conventional oxygen Wiki | 0.33 |
| drug917 | Q-NRG Metobolic Cart Device Wiki | 0.33 |
| drug712 | MultiStem Wiki | 0.33 |
| drug1144 | Thalidomide Wiki | 0.33 |
| drug135 | BVRS-GamVac Wiki | 0.33 |
| drug82 | Artemisinin / Artesunate Wiki | 0.33 |
| drug230 | CPAP Wiki | 0.33 |
| drug1339 | mechanical ventilation Wiki | 0.33 |
| drug1411 | thalidomide Wiki | 0.33 |
| drug475 | HFNO Wiki | 0.33 |
| drug1423 | washed microbiota transplantation Wiki | 0.33 |
| drug1089 | Stem Cell Educator-Treated Mononuclear Cells Apheresis Wiki | 0.33 |
| drug1326 | intradermal injection of BCG Vaccine Wiki | 0.33 |
| drug136 | BVRS-GamVac-Combi Wiki | 0.33 |
| drug713 | Multifrequency Bioimpedance Spectroscopy Wiki | 0.33 |
| drug365 | Dexamethasone injection Wiki | 0.24 |
| drug401 | Electronic questionnaire Wiki | 0.24 |
| drug833 | Peginterferon Lambda-1A Wiki | 0.24 |
| drug850 | Placebo Wiki | 0.03 |
Correlated MeSH Terms (9)
| Name (Synonyms) | Correlation | |
|---|---|---|
| D013577 | Syndrome NIH | 0.13 |
| D007249 | Inflammation NIH | 0.11 |
| D018352 | Coronavirus Infections NIH | 0.10 |
| D011014 | Pneumonia NIH | 0.07 |
| D045169 | Severe Acute Respiratory Syndrome NIH | 0.06 |
| D012127 | Respiratory Distress Syndrome, Newborn NIH | 0.04 |
| D012128 | Respiratory Distress Syndrome, Adult NIH | 0.04 |
| D003141 | Communicable Diseases NIH | 0.04 |
| D007239 | Infection NIH | 0.02 |
There are 9 clinical trials
Clinical Trials
1 Double-blind, Placebo-controlled Study With an Open Dose Selection Period for Assessing the Safety and Immunogenicity of the Drug "BVRS-GamVac-Combi", a Combined Vector Vaccine for the Prevention of the Middle East Respiratory Syndrome, Lyophilisate for the Preparation of a Solution for Intramuscular Administration, With the Participation of Healthy Volunteers
The Middle East respiratory syndrome coronavirus (MERS-CoV) was identified in 2012 during the first Middle East respiratory syndrome (MERS) outbreak. MERS-CoV causes an acute lower-respiratory infection in humans, with a fatality rate of ~34.5%. The aim of the study is to assess the safety and immunogenicity of heterologous adenoviral-based vaccine against MERS - BVRS-GamVac-Combi.
NCT04128059 MERS (Middle East Respiratory Syndrome) MERS Drug: BVRS-GamVac-Combi Other: placebo MeSH:Coronavirus Infections Syndrome
Primary Outcomes
Description: Determination of Number of Participants With Adverse Events
Measure: Number of Participants With Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of Number of Participants With Serious Adverse Events
Measure: Number of Participants With Serious Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of Number of Participants with Solicited Local and Systemic Adverse Events
Measure: Number of Participants with Solicited Local and Systemic Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of antibody levels against the MERS-CoV glycoprotein S measured by an ELISA vs. baseline values (phase 1, phase 2) and placebo (phase 2)
Measure: Antibody levels against the MERS-CoV glycoprotein S measured by an enzyme-linked immunosorbent assay (ELISA) Time: Time Frame for group 1 phase 1: at days 0, 7, 14, 21, 28, 42, 56 and 90. Time Frame for group 2 phase 1 and phase 2: at days 0, 7, 14, 21, 28, 35, 42, 56 and 90Secondary Outcomes
Description: determination of specific T-cell- mediated response vs. baseline values and placebo
Measure: Assessment of antigen-specific cell-mediated immune response Time: at 0, 14 and 28 days from the start of vaccination compared to baseline values (phase 1, phase 2) and placebo (phase 2)Description: Determination of the neutralizing antibody titer for a virus in virus neutralization reaction vs. baseline values and placebo
Measure: Neutralizing antibody levels Time: at days 0, 14 and 28 from the start of vaccination compared to baseline values2 Double-blind, Placebo-controlled Study With an Open Dose Selection Period for Assessing the Safety and Immunogenicity of the Drug "BVRS-GamVac", a Vector Vaccine for the Prevention of the Middle East Respiratory Syndrome, Lyophilisate for the Preparation of a Solution for Intramuscular Administration, With the Participation of Healthy Volunteers
The Middle East respiratory syndrome coronavirus (MERS-CoV) was identified in 2012 during the first Middle East respiratory syndrome (MERS) outbreak. MERS-CoV causes an acute lower-respiratory infection in humans, with a fatality rate of ~34.5%. The aim of the study is to assess the safety and immunogenicity of adenoviral-based vaccine against MERS - BVRS-GamVac.
NCT04130594 MERS (Middle East Respiratory Syndrome) MERS Biological: BVRS-GamVac Other: placebo MeSH:Coronavirus Infections Syndrome
Primary Outcomes
Description: Determination of Number of Participants With Adverse Events
Measure: Number of Participants With Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of Number of Participants With Serious Adverse Events
Measure: Number of Participants With Serious Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of Number of Participants with Solicited Local and Systemic Adverse Events
Measure: Number of Participants with Solicited Local and Systemic Adverse Events Time: through the whole study, an average of 180 daysDescription: Determination of antibody levels against the MERS-CoV glycoprotein S measured by an ELISA vs. baseline values (phase 1, phase 2) and placebo (phase 2)
Measure: Antibody levels against the MERS-CoV glycoprotein S measured by an enzyme-linked immunosorbent assay (ELISA) Time: at days 0, 7, 14, 21, 28, 42, 56 and 90Secondary Outcomes
Description: determination of specific T-cell- mediated response vs. baseline values (phase 1, phase 2) and placebo (phase 2)
Measure: Assessment of antigen-specific cell-mediated immune response Time: at 0 and 14 days from the start of vaccination compared to baseline values (day 0)Description: Determination of the neutralizing antibody titer for a virus in virus neutralization reaction vs. baseline values
Measure: Neutralizing antibody levels Time: at days 0, 14 and 283 Washed Microbiota Transplantation for Patients With 2019-nCoV Infection: a Randomized, Double-blind, Placebo-controlled Study
Gut dysbiosis co-exists in patients with coronavirus pneumonia. Some of these patients would develop secondary bacterial infections and antibiotic-associated diarrhea (AAD). The recent study on using washed microbiota transplantation (WMT) as rescue therapy in critically ill patients with AAD demonstrated the important clinical benefits and safety of WMT. This clinical trial aims to evaluate the outcome of WMT combining with standard therapy for patients with 2019-novel coronavirus pneumonia, especially for those patients with dysbiosis-related conditions.
NCT04251767 COVID-19 Complicated With Refractory Intestinal Infections Other: washed microbiota transplantation Other: placebo MeSH:Infection Communicable Diseases
Primary Outcomes
Description: Common type: Fever, respiratory tract and other symptoms, imaging examination shows pneumonia; Severe type (meeting any of the following）: (1) Respiratory distress，respiratory rate ≥ 30 bmp; (2) Oxygen saturation ≤ 93%；(3)PaO2/FiO2 ≤ 300mmHg. Critically severe type (meeting any of the following）: (1) Respiratory failure requiring mechanical ventilation; (2) Shock; (3) Combining with other organ failures, requiring ICU monitoring and treatment.
Measure: Number of participants with improvement from severe type to common type Time: 2 weeks4 The Efficacy and Safety of Thalidomide in the Adjuvant Treatment of Moderate New Coronavirus (COVID-19) Pneumonia: a Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study
In December 2019, Wuhan, in Hubei province, China, became the center of an outbreak of pneumonia of unknown cause. In a short time, Chinese scientists had shared the genome information of a novel coronavirus (2019-nCoV) from these pneumonia patients and developed a real-time reverse transcription PCR (real time RT-PCR) diagnostic assay. In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Thalidomide has anti-inflammatory, anti-fibrotic, anti-angiogenesis, and immune regulation effects. This study is the first Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study at home and abroad to use immunomodulators to treat patients with COVID-19 infection.
NCT04273529 COVID-19 Thalidomide Drug: thalidomide Drug: placebo MeSH:Pneumonia
HPO:Pneumonia
Primary Outcomes
Description: TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours. Normalisation and alleviation criteria:
Fever - ≤36.6°C or -axilla, ≤37.2 °C oral or ≤37.8°C rectal or tympanic, Respiratory rate - ≤24/minute on room air, Oxygen saturation - >94% on room air, Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent.
Measure: Time to Clinical recoveryTime to Clinical Recovery (TTCR) Time: up to 28 days
Secondary Outcomes
Description: baseline SpO2 during screening, PaO2/FiO2 ＜300mmHg or a respiratory rate ≥ 24 breaths per min without supplemental oxygen
Measure: All cause mortality Time: up to 28 days
Description: Defined as SPO2≤ 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support.
Measure: Frequency of respiratory progression Time: up to 28 days
Description: in those with fever at enrolment
Measure: Time to defervescence Time: up to 28 days
Other Outcomes
Description: in those with cough at enrolment rated severe or moderate
Measure: Time to cough reported as mild or absent Time: up to 28 days
Description: patients with moderate / severe dyspnea when enrolled
Measure: Respiratory improvement time Time: up to 28 days
Measure: Frequency of requirement for supplemental oxygen or non-invasive ventilation Time: up to 28 days
Measure: Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimen Time: up to 28 days
Measure: Change (reduction) in 2019-nCoV viral load in upper respiratory tract specimen as assessed by area under viral load curve Time: up to 28 days
Measure: Frequency of requirement for mechanical ventilation Time: up to 28 days
Measure: Frequency of serious adverse events Time: up to 28 days
Measure: Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10，MCP1, MIP1α and other cytokine expression levels before and after treatment Time: up to 28 days
5 The Efficacy and Safety of Thalidomide Combined With Low-dose Hormones in the Treatment of Severe New Coronavirus (COVID-19) Pneumonia: a Prospective, Multicenter, Randomized, Double-blind, Placebo, Parallel Controlled Clinical Study
Primary Outcomes
Description: TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours. Normalisation and alleviation criteria: Fever - ≤36.6°C or -axilla, ≤37.2 °C oral or ≤37.8°C rectal or tympanic, Respiratory rate - ≤24/minute on room air, Oxygen saturation - >94% on room air, Cough - mild or absent on a patient reported scale of severe, moderate, mild, absent.
Measure: Time to Clinical recoveryTime to Clinical Recovery (TTCR) Time: up to 28 daysSecondary Outcomes
Description: baseline SpO2 during screening, PaO2/FiO2 ＜300mmHg or a respiratory rate ≥ 24 breaths per min without supplemental oxygen
Measure: All cause mortality Time: up to 28 daysDescription: Defined as SPO2≤ 94% on room air or PaO2/FiO2 <300mmHg and requirement for supplemental oxygen or more advanced ventilator support.
Measure: Frequency of respiratory progression Time: up to 28 daysDescription: in those with fever at enrolment
Measure: Time to defervescence Time: up to 28 daysOther Outcomes
Description: in those with cough at enrolment rated severe or moderate
Measure: Time to cough reported as mild or absent Time: up to 28 daysDescription: patients with moderate / severe dyspnea when enrolled
Measure: Respiratory improvement time Time: up to 28 daysMeasure: Frequency of requirement for supplemental oxygen or non-invasive ventilation Time: up to 28 days
Measure: Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimen Time: up to 28 days
Measure: Change (reduction) in 2019-nCoV viral load in upper respiratory tract specimen as assessed by area under viral load curve Time: up to 28 days
Measure: Frequency of requirement for mechanical ventilation Time: up to 28 days
Measure: Frequency of serious adverse events Time: up to 28 days
Measure: Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10，MCP1, MIP1α and other cytokine expression levels before and after treatment Time: up to 28 days
In view of the fact that there is currently no effective antiviral therapy, the prevention or treatment of lung injury caused by COVID-19 can be an alternative target for current treatment. Patients with severe COVID-19 have rapid disease progression and high mortality. There is currently no effective treatment method, which may be related to the excessive immune response caused by cytokine storm. This study will evaluate thalidomide combined with low-dose hormone adjuvant therapy for severe COVID-19 Patient effectiveness and safety.
NCT04273581 COVID-19 Thalidomide Drug: placebo Drug: Thalidomide
Primary Outcomes
Description: TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death). Six-category ordinal scale: 6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy; 3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC); 2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge. Abbreviation: IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation; HFNC, High-flow nasal cannula.
Measure: Time to Clinical Improvement (TTCI) Time: up to 28 daysSecondary Outcomes
Description: Clinical status, assessed by the ordinal scale at fixed time points
Measure: Clinical status Time: days 7, 14, 21, and 28Measure: Time to Hospital Discharge OR NEWS2 (National Early Warning Score 2) of ≤ 2 maintained for 24 hours Time: up to 28 days
Measure: All cause mortality Time: up to 28 days
Measure: Duration (days) of mechanical ventilation Time: up to 28 days
Measure: Duration (days) of extracorporeal membrane oxygenation Time: up to 28 days
Measure: Duration (days) of supplemental oxygenation Time: up to 28 days
Measure: Length of hospital stay (days) Time: up to 28 days
Measure: Time to 2019-nCoV RT-PCR negativity in upper and lower respiratory tract specimens Time: up to 28 days
Measure: Change (reduction) in 2019-nCoV viral load in upper and lower respiratory tract specimens as assessed by area under viral load curve. Time: up to 28 days
Measure: Frequency of serious adverse drug events Time: up to 28 days
Measure: Serum TNF-α, IL-1β, IL-2, IL-6, IL-7, IL-10, GSCF, IP10#MCP1, MIP1α and other cytokine expression levels before and after treatment Time: up to 28 days
6 Dexamethasone and Oxygen Support Strategies in ICU Patients With Covid-19 pneumonia_COVIDICUS
The main manifestation of COVID-19 is acute hypoxemic respiratory failure (AHRF). In patients with AHRF, the need for invasive mechanical ventilation is associated with high mortality. Two hypotheses will be tested in this study. The first hypothesis is the benefit of corticosteroid therapy on severe COVID-19 infection admitted in ICU in terms of survival. The second hypothesis is that, in the subset of patients free of mechanical ventilation at admission, either Continuous Positive Airway Pressure (CPAP) or High-Flow Nasal Oxygen (HFNO) allows to reduce intubation rate safely during COVID-19 related acute hypoxemic respiratory failure.
NCT04344730 Acute Hypoxemic Respiratory Failure COVID-19 Drug: Dexamethasone injection Drug: placebo Procedure: conventional oxygen Procedure: CPAP Procedure: HFNO Procedure: mechanical ventilation MeSH:Pneumonia Respiratory Insufficiency
HPO:Pneumonia
Primary Outcomes
Description: The time-to-death from all causes within the first 60 days after randomization.
Measure: The time-to-death from all causes Time: day-60
Description: the time to need for mechanical ventilation (MV), as defined by any of the 3 criteria for intubation within the first 28 days after randomization.
Measure: The time to need for mechanical ventilation (MV) Time: day-28.
Secondary Outcomes
Description: The cycle threshold for SARS-CoV-2 PCR at baseline, day 7 and day 10 in samples of the same origin (preferably subglottic i.e. bronchoalveolar lavage or tracheal aspiration, otherwise nasopharyngeal swab)
Measure: The viral load in the respiratory tract Time: day-10
Description: Proportion of patients with at least one episode of any healthcare-associated infection between randomization and D28
Measure: Number of patient with at least one episode of healthcare-associated infections Time: day-28
Description: To compare the exposition to mechanical ventilation
Measure: Number of days alive without mechanical ventilation Time: day-28
Description: Changes in SOFA (Sepsis-related Organ Failure Assessment) score. (min = 0 for normal status max = 24 for worse status)
Measure: Measure of SOFA score Time: day-28
Description: to compare the exposition to renal replacement therapy
Measure: Number of days alive without renal replacement therapy Time: day-28
Description: To compare the lengths of ICU
Measure: Lengths of ICU-stay Time: day-60
Description: To compare the lengths of hospital-stay
Measure: Lengths of hospital-stay Time: day-60
Description: Proportion of patients with severe hypoxemia, which is defined as an oxygen saturation of less than 80% during the same interval during the interval between induction and 2 minutes after tracheal intubation
Measure: Number of patients with severe hypoxemia, Time: day 60
Description: Proportion of patients with cardiac arrest within 1 hour after intubation
Measure: Number of patients with cardiac arrest within 1 hour after intubation Time: day 60
7 Application of BCG Vaccine for Immune-prophylaxis Among Egyptian Healthcare Workers During the Pandemic of COVID-19
Primary Outcomes
Description: The time-to-death from all causes within the first 60 days after randomization.
Measure: The time-to-death from all causes Time: day-60Description: the time to need for mechanical ventilation (MV), as defined by any of the 3 criteria for intubation within the first 28 days after randomization.
Measure: The time to need for mechanical ventilation (MV) Time: day-28.Secondary Outcomes
Description: The cycle threshold for SARS-CoV-2 PCR at baseline, day 7 and day 10 in samples of the same origin (preferably subglottic i.e. bronchoalveolar lavage or tracheal aspiration, otherwise nasopharyngeal swab)
Measure: The viral load in the respiratory tract Time: day-10Description: Proportion of patients with at least one episode of any healthcare-associated infection between randomization and D28
Measure: Number of patient with at least one episode of healthcare-associated infections Time: day-28Description: To compare the exposition to mechanical ventilation
Measure: Number of days alive without mechanical ventilation Time: day-28Description: Changes in SOFA (Sepsis-related Organ Failure Assessment) score. (min = 0 for normal status max = 24 for worse status)
Measure: Measure of SOFA score Time: day-28Description: to compare the exposition to renal replacement therapy
Measure: Number of days alive without renal replacement therapy Time: day-28Description: To compare the lengths of ICU
Measure: Lengths of ICU-stay Time: day-60Description: To compare the lengths of hospital-stay
Measure: Lengths of hospital-stay Time: day-60Description: Proportion of patients with severe hypoxemia, which is defined as an oxygen saturation of less than 80% during the same interval during the interval between induction and 2 minutes after tracheal intubation
Measure: Number of patients with severe hypoxemia, Time: day 60Description: Proportion of patients with cardiac arrest within 1 hour after intubation
Measure: Number of patients with cardiac arrest within 1 hour after intubation Time: day 60Phase III Placebo-controlled adaptive multi-centre randomized controlled trial Interventional (Clinical Trial). The study will include nine hundred healthcare workers in the isolation hospitals for COVID-19 cases; they will be randomly assigned to receive either BCG vaccine or normal saline.
NCT04350931 Coronavirus Disease (COVID-19) Biological: intradermal injection of BCG Vaccine Other: placebo MeSH:Coronavirus Infections
Primary Outcomes
Description: Estimate the incidence of confirmed COVID-19 among the healthcare workers in isolation hospitals
Measure: incidence of confirmed COVID-19 Time: 9 monthsDescription: Evaluate the effectiveness of BCG vaccine in protecting the healthcare workers in isolation hospitals against the risk of COVID-19 infection by detecting any positive cases among vaccinated healthscare workers
Measure: Effectiveness of BCG vaccine Time: 9 months8 Interferon Lambda for Immediate Antiviral Therapy at Diagnosis (ILIAD): A Phase II Randomized, Double-blind, Placebo-controlled, Multicenter Trial to Evaluate the Effect of Peginterferon Lambda for the Treatment of COVID-19
Interferon lambda is one of the main arms of the innate antiviral immune response and is critical for controlling respiratory viral infections in mice. Interferon lambda has a better side effect profile than other interferons because of the limited tissue distribution of its receptor. Peginterferon lambda is a long-acting form that has been studied extensively in human trials in viral hepatitis, confirming its safety. We propose to evaluate peginterferon-lambda in ambulatory and hospitalized patients with mild to moderate COVID-19.
NCT04354259 Sars-CoV2 Covid-19 Drug: Peginterferon Lambda-1A Other: placebo
Primary Outcomes
Description: The proportion of participants with negative SARS-CoV-2 RNA on nasopharyngeal swab.
Measure: Cohort A (Ambulatory) - Proportion swab negative at day 7 (Primary efficacy endpoint) Time: At day 7Description: The rate of treatment-emergent and treatment-related serious adverse events (SAEs)
Measure: Cohort A (Ambulatory) - Treatment-emergent and treatment related serious adverse events (Primary Safety Endpoint) Time: Day 0 to Day 30Description: Time to SARS-CoV-2 RNA negativity.
Measure: Cohort B (Hospitalized) - Time to viral negativity (Primary Efficacy Endpoint) Time: Day 0 to day 28Description: The rate of treatment-emergent and treatment-related serious adverse events (SAEs)
Measure: Cohort B (Hospitalized) - treatment-emergent and treatment-related serious adverse events (Primary Safety Endpoint) Time: Day 0 to Day 30Secondary Outcomes
Description: Time to resolution of symptoms (fever, cough, diarrhea)
Measure: Cohort A (Ambulatory) - Symptom Resolution (Clinical Outcome #1) Time: Day 0 to Day 14Description: Change in relative categorical symptom scores (respiratory, gastrointestinal, fever) - none, mild, moderate, severe and no change, worse, better
Measure: Cohort A (Ambulatory) - Symptom severity scores (Clinical Outcome #2) Time: Day 0 to Day 7Description: Proportion with need for hospital admission
Measure: Cohort A (Ambulatory) - Hospitalization (Clinical Outcome #3) Time: Day 0 to Day 14Description: Adverse events and serious adverse events
Measure: Cohort A (Ambulatory) - Adverse and serious adverse events (Clinical Outcome #4) Time: Day 0 to Day 14Description: Proportion negative for SARS-CoV-2 RNA by nasopharyngeal swab
Measure: Cohort A (Ambulatory) - Swab negative at day 3 (Virologic/Immunological Outcome #1) Time: At Day 3Description: Time to SARS-CoV-2 RNA negativity on mid-turbinate nasal swab or saliva
Measure: Cohort A (Ambulatory) - Time RNA negativity (Virologic/Immunological Outcome #2) Time: Day 0 to Day 14Description: Proportion with SARS-CoV-2 RNA in blood.
Measure: Cohort A (Ambulatory) - Proportion viremic (Virologic/Immunological Outcome #3) Time: Day 0 and Day 7Description: Proportion with SARS-CoV-2 antibodies blood
Measure: Cohort A (Ambulatory) - Proportion with antibodies (Virologic/Immunological Outcome #4) Time: Day 0 and Day 7Description: Correlation of virologic response with interferon lambda 4 (IFNL4) genotype
Measure: Cohort A (Ambulatory) - Correlation with interferon lambda 4 genotype (Virologic/Immunological Outcome #5) Time: Through day 7Description: Proportion with symptom development in household contacts (categorical symptom type yes/no)
Measure: Cohort A (Ambulatory) - Symptoms in household contacts (Transmission Outcome #1) Time: Day 0 to Day 14Description: Proportion with confirmed diagnosis of COVID-19 in household contacts
Measure: Cohort A (Ambulatory) - COVID-19 in household contacts (Transmission Outcome #2) Time: At Day 30Description: Proportion with ICU admission during hospitalization
Measure: Cohort B (Hospitalized) - ICU admission (Clinical Outcome #1) Time: Day 0 to day 30Description: Proportion with need for intubation
Measure: Cohort B (Hospitalized) - Need for intubation (Clinical Outcome #2) Time: Day 0 to Day 14Description: Length of hospital stay (days)
Measure: Cohort B (Hospitalized) - Length of hospital stay (Clinical Outcome #3) Time: Day 0 to Day 14Description: Change in respiratory symptom score (score 0 to 7 with higher scores indicating more severe disease)
Measure: Cohort B (Hospitalized) - Change in respiratory symptom score (Clinical Outcome #4) Time: Day 0 to 7 and Day 0 to 14Description: Proportion with readmission to hospital
Measure: Cohort B (Hospitalized) - Readmission to hospital (Clinical Outcome #5) Time: By day 30 and Day 90Description: All-cause mortality
Measure: Cohort B (Hospitalized) - All-cause mortality (Clinical Outcome #6) Time: At day 30 and day 90Description: COVID-19-related mortality
Measure: Cohort B (Hospitalized) - COVID-19-related mortality (Clinical Outcome #7) Time: At day 30Description: Adverse (AEs) and Serious Adverse Events (SAEs)
Measure: Cohort B (Hospitalized) - Adverse (AEs) and Serious Adverse Events (SAEs) (Clinical Outcome #8) Time: Day 0 to day 30Description: Frequency of dose reduction or dose omission for the second dose of peginterferon lambda
Measure: Cohort B (Hospitalized) - Dose reduction or dose omission (Clinical Outcome #9) Time: Day 7 to day 11Description: Proportion negative for SARS-CoV-2 RNA by nasopharyngeal swab.
Measure: Cohort B (Hospitalized) - Proportion negative swab. (Virologic/Immunological Outcome #1) Time: Day 7Description: Proportion negative for SARS-CoV-2 by nasopharyngeal swab
Measure: Cohort B (Hospitalized) - Proportion negative by day 14 (Virologic/Immunological Outcome) #2) Time: Day 14Description: Time to SARS-CoV-2 RNA negativity by rectal swab
Measure: Cohort B (Hospitalized) - Time to negativity by rectal swab (Virologic/Immunological Outcome #3) Time: Day 0 to day 14Description: Correlation of virologic response with interferon lambda 4 (IFNL4) genotype
Measure: Cohort B (Hospitalized) - Correlation with interferon lambda 4 (IFNL4) genotype (Virologic/Immunological Outcome #4) Time: Through Day 14Description: Proportion with SARS-CoV-2 Antibody.
Measure: Cohort B (Hospitalized) - Proportion with Antibody (Virologic/Immunological Outcome #6) Time: At Day 7 and Day 14Description: Proportion with SARS-CoV-2 RNA in blood
Measure: Cohort B (Hospitalized) - Proportion with viremia (Virologic/Immunological Outcome #7) Time: Day 0, Day 7, and Day 149 Evaluating the Efficacy of Artesunate in Adults With Mild Symptoms of COVID-19
Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus. At this time, there are no specific vaccines or treatments for COVID-19. However, there are many ongoing clinical trials evaluating potential treatments Drugs used to treat malaria infection has shown to be beneficial for many other diseases, including viral infections. In this Clinical trial, Investigators will evaluate the effect of Artemisinin / Artesunate on morbidity of COVID-19 patients in decreasing the course of the disease and viral load in symptomatic stable positive swab COVID-19 patients. Investigators are hypothesizing that due to the antiviral properties of this drug it will help as a treatment for the COVID -19 patients. In improving their condition and clearing the virus load,
NCT04387240 Covid 19 Positive Corona Virus Infection Drug: Artemisinin / Artesunate Other: placebo MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Description: absence of the virus shedding evidenced by negative swabs
Measure: length of stay in hospital Time: within the first 6 days interventionSecondary Outcomes
Description: reduction of morbidity and mortality
Measure: number of ICU admission Time: 14 daysDescription: finding the time that the symptoms disappear
Measure: resolution of symptoms Time: 6 days - 10 day