Covid 19 Research using Clinical Trials (Home Page)
Lopinavir/ritonavirWiki
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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation
Correlated Drug Terms (38)
| Name (Synonyms) | Correlation | |
|---|---|---|
| drug396 | Hydroxychloroquine sulfate Wiki | 0.45 |
| drug730 | Sampling salivary Wiki | 0.32 |
| drug713 | SARILUMAB Wiki | 0.32 |
| drug309 | Five-days oseltamivir Wiki | 0.32 |
| drug108 | Baricitinib (janus kinase inhibitor) Wiki | 0.32 |
| drug311 | Fixed-duration higher dose Hydrocortisone Wiki | 0.32 |
| drug491 | Macrolide administered for 3-5 days Wiki | 0.32 |
| drug413 | Imatinib tablets Wiki | 0.32 |
| drug831 | Ten-days oseltamivir Wiki | 0.32 |
| drug178 | Ceftaroline Wiki | 0.32 |
| drug380 | Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki | 0.32 |
| drug646 | Practice details Wiki | 0.32 |
| drug366 | Hydroxychloroquine + lopinavir/ritonavir Wiki | 0.32 |
| drug518 | Moxifloxacin or Levofloxacin Wiki | 0.32 |
| drug578 | Online Survey Wiki | 0.32 |
| drug492 | Macrolide administered for up to 14 days Wiki | 0.32 |
| drug310 | Fixed-duration Hydrocortisone Wiki | 0.32 |
| drug698 | Ribavirin Wiki | 0.32 |
| drug433 | Interferon-β1a Wiki | 0.32 |
| drug747 | Shock-dependent hydrocortisone Wiki | 0.32 |
| drug179 | Ceftriaxone Wiki | 0.32 |
| drug45 | Amoxicillin-clavulanate Wiki | 0.32 |
| drug110 | Baricitinib Oral Tablet Wiki | 0.32 |
| drug1015 | remdesivir Wiki | 0.32 |
| drug347 | Hidroxicloroquine Wiki | 0.32 |
| drug615 | Piperacillin-tazobactam Wiki | 0.32 |
| drug671 | Questionnaires Wiki | 0.22 |
| drug29 | Abidol hydrochloride Wiki | 0.22 |
| drug429 | Interferon Beta-1B Wiki | 0.18 |
| drug428 | Interferon Beta-1A Wiki | 0.18 |
| drug582 | Oseltamivir Wiki | 0.14 |
| drug732 | Sarilumab Wiki | 0.13 |
| drug46 | Anakinra Wiki | 0.12 |
| drug360 | Hydroxychloroquine Wiki | 0.12 |
| drug775 | Standard of care Wiki | 0.11 |
| drug691 | Remdesivir Wiki | 0.10 |
| drug854 | Tocilizumab Wiki | 0.08 |
| drug627 | Placebo oral tablet Wiki | 0.07 |
There are 10 clinical trials
Clinical Trials
1 Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia
REMAP-CAP is a randomised, embedded, multifactorial, adaptive platform trial for community-acquired pneumonia. The purpose of this study is to evaluate the effect of a range of interventions to improve outcome ofon patients admitted to intensive care with community-acquired pneumonia. In addition, REMAP-CAP provides and adaptive research platform for evaluation of multiple treatment modalities in the event of a respiratory pandemic resulting in critical illness. REMAP-COVID is a sub-platform of REMAP-CAP that evaluates treatments specific to COVID-19.
NCT02735707 Community-acquired Pneumonia, Influenza, COVID-19 Drug: Fixed-duration Hydrocortisone Drug: Shock-dependent hydrocortisone Drug: Ceftriaxone Drug: Moxifloxacin or Levofloxacin Drug: Piperacillin-tazobactam Drug: Ceftaroline Drug: Amoxicillin-clavulanate Drug: Macrolide administered for 3-5 days Drug: Macrolide administered for up to 14 days Drug: Five-days oseltamivir Drug: Ten-days oseltamivir Drug: Lopinavir/ritonavir Drug: Hydroxychloroquine Drug: Hydroxychloroquine + lopinavir/ritonavir Drug: Interferon-β1a Drug: Anakinra Drug: Fixed-duration higher dose Hydrocortisone Drug: Tocilizumab Drug: Sarilumab MeSH:Pneumonia
HPO:Pneumonia
Primary Outcomes
Measure: All-cause mortality Time: Day 90
Description: Primary end-point for patients with suspected or proven COVID-19 pandemic infection
Measure: Days alive and outside of ICU Time: Day 21
Secondary Outcomes
Measure: ICU Mortality Time: Day 90
Measure: ICU length of stay Time: Day 90
Measure: Hospital length of stay Time: Day 90
Measure: Ventilator free days Time: Day 28
Measure: Organ failure free days Time: Day 28
Measure: All-cause mortality Time: 6 months
Description: EQ5D-5L and WHODAS 2.0 (not completed in all regions)
Measure: Health-related Quality of life assessment Time: 6 months
Measure: Proportion of intubated patients who receive a tracheostomy Time: Day 28
Description: Characterised as home, rehabilitation hospital, nursing home or long-term care facility, or another acute hospital
Measure: Destination at time of hospital discharge Time: Free text Day 90
Measure: Readmission to the index ICU during the index hospitalization Time: Day 90
Measure: World Health Organisation 8-point ordinal scale outcome Time: Hospital discharge
Other Outcomes
Description: Antibiotic Domain specific outcome
Measure: Occurrence of multi-resistant organism colonisation/infection Time: Day 90, censored at hospital discharge
Description: Antibiotic Domain specific outcome
Measure: Occurrence clostridium difficile Time: Day 90, censored at hospital discharge
Description: Macrolide Duration domain specific outcome, and COVID-19 Antiviral Domain specific outcome.
Measure: Occurrence of serious ventricular arrhythmia (including ventricular fibrillation) or sudden unexpected death Time: Day 90, censored at hospital discharge
Description: Antiviral Domain specific outcome. Only required at selected sites.
Measure: Change from baseline influenza virus levels in upper and lower respiratory tract specimens Time: Day 3, up to Day 7
Description: COVID-19 Antiviral Domain and COVID-19 Immune Modulation Domain specific endpoint
Measure: Serial detection of SARS-CoV-2 in upper or lower respiratory tract specimens (using only specimens collected for routine clinical testing) Time: Day 90, censored at hospital discharge
2 An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Three Antiviral Drugs(Abidol Hydrochloride, Oseltamivir and Lopinavir/Ritonavir) in the Treatment of 2019-nCoV Pneumonia.
Primary Outcomes
Measure: All-cause mortality Time: Day 90Description: Primary end-point for patients with suspected or proven COVID-19 pandemic infection
Measure: Days alive and outside of ICU Time: Day 21Secondary Outcomes
Measure: ICU Mortality Time: Day 90Measure: ICU length of stay Time: Day 90
Measure: Hospital length of stay Time: Day 90
Measure: Ventilator free days Time: Day 28
Measure: Organ failure free days Time: Day 28
Measure: All-cause mortality Time: 6 months
Description: EQ5D-5L and WHODAS 2.0 (not completed in all regions)
Measure: Health-related Quality of life assessment Time: 6 monthsMeasure: Proportion of intubated patients who receive a tracheostomy Time: Day 28
Description: Characterised as home, rehabilitation hospital, nursing home or long-term care facility, or another acute hospital
Measure: Destination at time of hospital discharge Time: Free text Day 90Measure: Readmission to the index ICU during the index hospitalization Time: Day 90
Measure: World Health Organisation 8-point ordinal scale outcome Time: Hospital discharge
Other Outcomes
Description: Antibiotic Domain specific outcome
Measure: Occurrence of multi-resistant organism colonisation/infection Time: Day 90, censored at hospital dischargeDescription: Antibiotic Domain specific outcome
Measure: Occurrence clostridium difficile Time: Day 90, censored at hospital dischargeDescription: Macrolide Duration domain specific outcome, and COVID-19 Antiviral Domain specific outcome.
Measure: Occurrence of serious ventricular arrhythmia (including ventricular fibrillation) or sudden unexpected death Time: Day 90, censored at hospital dischargeDescription: Antiviral Domain specific outcome. Only required at selected sites.
Measure: Change from baseline influenza virus levels in upper and lower respiratory tract specimens Time: Day 3, up to Day 7Description: COVID-19 Antiviral Domain and COVID-19 Immune Modulation Domain specific endpoint
Measure: Serial detection of SARS-CoV-2 in upper or lower respiratory tract specimens (using only specimens collected for routine clinical testing) Time: Day 90, censored at hospital dischargeAt present, there is no specific and effective antiviral therapy.In this study, an open, prospective/retrospective, randomized controlled cohort study was designed to compare the efficacy of three antiviral drugs in the treatment of 2019-nCoV pneumonia by studying the efficacy of abidol hydrochloride, oseltamivir and lopinavir/ritonavir in the treatment of 2019-nCoV viral pneumonia, and to explore effective antiviral drugs for new coronavirus. To provide reliable evidence-based medicine basis for the treatment of viral pneumonia caused by new coronavirus infection.
NCT04255017 2019-nCoV Drug: Abidol hydrochloride Drug: Oseltamivir Drug: Lopinavir/ritonavir MeSH:Pneumonia
HPO:Pneumonia
Primary Outcomes
Description: A: For mild patients : fever, cough and other symptoms relieved with improved lung CT; B:For severe patients : fever, cough and other symptoms relieved with improved lung CT,SPO2> 93% or PaO2/FiO2>300mmHg (1mmHg=0.133Kpa);
Measure: Rate of disease remission Time: two weeks
Description: Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.
Measure: Time for lung recovery Time: two weeks
Secondary Outcomes
Measure: Rate of no fever Time: two weeks
Measure: Rate of respiratory symptom remission Time: two weeks
Measure: Rate of lung imaging recovery Time: two weeks
Measure: Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery Time: two weeks
Measure: Rate of undetectable viral RNA Time: two weeks
3 An Open-label Randomized Controlled Trial on Lopinavir/ Ritonavir, Ribavirin and Interferon Beta 1b Combination Versus Lopinavir/ Ritonavir Alone, as Treatment for 2019 Novel Coronavirus Infection
Primary Outcomes
Description: A: For mild patients : fever, cough and other symptoms relieved with improved lung CT; B:For severe patients : fever, cough and other symptoms relieved with improved lung CT,SPO2> 93% or PaO2/FiO2>300mmHg (1mmHg=0.133Kpa);
Measure: Rate of disease remission Time: two weeksDescription: Compare the average time of lung imaging recovery after 2 weeks of treatment in each group.
Measure: Time for lung recovery Time: two weeksSecondary Outcomes
Measure: Rate of no fever Time: two weeksMeasure: Rate of respiratory symptom remission Time: two weeks
Measure: Rate of lung imaging recovery Time: two weeks
Measure: Rate of CRP,ES,Biochemical criterion(CK,ALT,Mb) recovery Time: two weeks
Measure: Rate of undetectable viral RNA Time: two weeks
A combination of lopinavir/ ritonavir, ribavirin and interferon beta-1b will expedite the recovery, suppress the viral load, shorten hospitalisation and reduce mortality in patients with 2019-n-CoV infection compared with to lopinavir/ ritonavir
NCT04276688 Novel Coronavirus Infection Drug: Lopinavir/ritonavir Drug: Ribavirin Drug: Interferon Beta-1B MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Description: Time to negative NPS 2019-n-CoV RT-PCR
Measure: Time to negative NPS Time: Up to 1 monthSecondary Outcomes
Description: Time to negative saliva 2019-n-CoV RT-PCR
Measure: Time to negative saliva Time: Up to 1 monthDescription: Time to NEWS of 0
Measure: Time to clinical improvement Time: Up to 1 monthDescription: Length of hospitalisation
Measure: Hospitalisation Time: Up to 1 monthDescription: 30-day mortality
Measure: Mortality Time: Up to 1 monthDescription: Cytokine/ chemokine changes
Measure: Immune reaction Time: up to 1 monthDescription: Adverse events during treatment
Measure: Adverse events Time: up to 1 monthDescription: Time to negative NPS, saliva, urine and stool 2019-n-CoV RT-PCR
Measure: Time to negative all clinical specimens Time: up to 1 month4 Randomized Controlled Clinical Trials of Lopinavir/Ritonavir or Hydroxychloroquine in Patients With Mild Coronavirus Disease (COVID-19)
In vitro studies revealed that lopinavir/ritonavir and hydroxychloroquine have antiviral activity against Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). However, there is no clinical studies on the reduction of viral load in patients with COVID-19. This study investigate whether lopinavir/ritonavir or hydroxychloroquine reduces viral load from respiratory specimen in patients with mild COVID-19.
NCT04307693 COVID-19 Drug: Lopinavir/ritonavir Drug: Hydroxychloroquine sulfate MeSH:Coronavirus Infections
Primary Outcomes
Description: Area under the curve (AUC) of Ct value or viral copies number per mL
Measure: Viral load Time: hospital day 3, 5, 7, 10, 14, 18Secondary Outcomes
Description: Viral load change (log10 viral load assessed by reverse transcription-PCR) during hospital day 3, 5, 7, 10, 14, 18)
Measure: Viral load change Time: hospital day 3, 5, 7, 10, 14, 18Description: Time to clinical improvement (TTCI) is defined as the time to normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough within at least 72 hours
Measure: Time to clinical improvement (TTCI) Time: up to 28 daysDescription: Percentage of progression to supplemental oxygen requirement by day 7
Measure: Percentage of progression to supplemental oxygen requirement by day 7 Time: hospital day 7Description: Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7
Measure: Time to NEWS2 (National Early Warning Score 2) of 3 or more maintained for 24 hours by day 7 Time: hospital day 7Description: Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission
Measure: Time to clinical failure, defined as the time to death, mechanical ventilation, or ICU admission Time: up to 28 daysDescription: Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7
Measure: Rate of switch to Lopinavir/ritonavir or hydroxychloroquine by day 7 Time: hospital day 7Description: Safety and tolerability, as assessed by adverse effects
Measure: adverse effects Time: up to 28 daysDescription: Concentration of Lopinavir/ritonavir and hydroxychloroquine
Measure: Concentration of Lopinavir/ritonavir and hydroxychloroquine Time: 1, 2, 4, 5, 12 hours after taking intervention medicine5 Multi-centre, Adaptive, Randomized Trial of the Safety and Efficacy of Treatments of COVID-19 in Hospitalized Adults
This study is a multi-centre, adaptive, randomized, open clinical trial of the safety and efficacy of treatments for COVID-19 in hospitalized adults. The study is a multi-centre/country trial that will be conducted in various sites in Europe with Inserm as sponsor. Adults (≥18 year-old) hospitalized for COVID-19 with SpO2 ≤ 94% on room air OR acute respiratory failure requiring supplemental oxygen or ventilatory support will be randomized between 4 treatment arms, each to be given in addition to the usual standard of care (SoC) in the participating hospital: SoC alone versus SoC + Remdesivir versus SoC + Lopinavir/Ritonavir versus SoC + Lopinavir/Ritonavir plus interferon ß-1a versus SoC + Hydroxychloroquine. Randomization will be stratified by European region and severity of illness at enrollment (moderate disease: patients NOT requiring non-invasive ventilation NOR high flow oxygen devices NOR invasive mechanical ventilation NOR ECMO and severe disease: patients requiring non-invasive ventilation OR high flow oxygen devices OR invasive mechanical ventilation OR ECMO). The interim trial results will be monitored by a Data Monitoring Committee, and if at any stage evidence emerges that any one treatment arm is definitely inferior then it will be centrally decided that that arm will be discontinued. Conversely, if good evidence emerges while the trial is continuing that some other treatment(s) should also be being evaluated then it will be centrally decided that one or more extra arms will be added while the trial is in progress. The primary objective of the study is to evaluate the clinical efficacy and safety of different investigational therapeutics relative to the control arm in patients hospitalized with COVID-19, the primary endpoint is the subject clinical status (on a 7-point ordinal scale) at day 15.
NCT04315948 Corona Virus Infection Drug: Remdesivir Drug: Lopinavir/ritonavir Drug: Interferon Beta-1A Drug: Hydroxychloroquine Other: Standard of care MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases
Primary Outcomes
Description: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.
Measure: Percentage of subjects reporting each severity rating on a 7-point ordinal scale Time: Day 15Secondary Outcomes
Description: Time to an improvement of one category from admission on an ordinal scale. Subject clinical status on an ordinal scale at days 3, 5, 8, 11, and 29. Mean change in the ranking on an ordinal scale from baseline to days 3, 5, 8, 11, 15 and 29 from baseline.
Measure: Percentage of subjects reporting each severity rating on a 7-point on an ordinal scale Time: Days 3, 5, 8, 11, 15 and 29Description: • Change from baseline to days 3, 5, 8, 11, 15, and 29 in NEWS.
Measure: The time to discharge or to a NEWS of ≤ 2 and maintained for 24 hours, whichever occurs first. Time: Days 3, 5, 8, 11, 15 and 29Measure: Number of oxygenation free days in the first 28 days Time: 29 days
Measure: Incidence of new oxygen use, non-invasive ventilation or high flow oxygen devices during the trial. Time: 29 days
Measure: Duration of new oxygen use, non-invasive ventilation or high flow oxygen devices during the trial. Time: 29 days
Measure: Ventilator free days in the first 28 days Time: 29 days
Measure: Incidence of new mechanical ventilation use during the trial. Time: 29 days
Description: • Duration of hospitalization (days).
Measure: Hospitalization Time: 29 daysDescription: Rate of mortality
Measure: Mortality Time: In hospital, Day 28, Day 90Measure: Cumulative incidence of serious adverse events (SAEs) Time: 29 days
Measure: Cumulative incidence of Grade 3 and 4 adverse events (AEs) Time: 29 days
Measure: Number of participants with a discontinuation or temporary suspension of study drugs (for any reason) Time: 29 days
Measure: Changes from baseline in blood white cell count Time: 29 days
Measure: Changes from baseline in haemoglobin Time: 29 days
Measure: Changes from baseline in platelets Time: 29 days
Measure: Changes from baseline in creatinine Time: 29 days
Measure: Changes from baseline in blood electrolytes (including kaliemia) Time: 29 days
Measure: Changes from baseline in prothrombine time Time: 29 days
Measure: Changes from baseline in international normalized ratio (INR) Time: 29 days
Measure: Changes from baseline in glucose Time: 29 days
Measure: Changes from baseline in total bilirubin Time: 29 days
Measure: Changes from baseline in alanine aminotransferase (ALT) Time: 29 days
Measure: Changes from baseline in aspartate aminotransferase (AST) Time: 29 days
Other Outcomes
Measure: Percent of subjects with SARS-CoV-2 detectable in nasopharyngeal sample Time: Days 3, 5, 8, 11, 15, 29Measure: Quantitative SARS-CoV-2 virus in nasopharyngeal sample Time: Days 3, 5, 8, 11, 15, 29
Measure: Quantitative SARS-CoV-2 virus in blood Time: Days 3, 5, 8 and 11
Description: On Day 1, plasma concentration 4 hours after the first administration (peak), and before the second administration (trough at H12) On Days 3, 5, 8 and 11, trough plasma concentration (before dose administration) while hospitalized
Measure: Plasma concentration of lopinavir Time: Days 1, 3, 5, 8 and 11Description: On Day 1, plasma concentration 4 hours after the first administration (peak), and before the second administration (trough at H12) On Days 3, 5, 8 and 11, trough plasma concentration (before dose administration) while hospitalized
Measure: Plasma concentration of hydroxychloroquine Time: Days 1, 3, 5, 8 and 116 COVID-19 Ring-based Prevention Trial With Lopinavir/Ritonavir
COVID-19 has rapidly evolved into a generalized global pandemic. Post-exposure prophylaxis (PEP) against on COVID-19 was identified as an urgent research priority by the WHO, and lopinavir/ritonavir (LPV/r) is a promising candidate for both COVID-19 treatment and PEP, with a good safety profile and global availability. This is a cluster randomized controlled trial (RCT) of oral LPV/r as PEP against COVID-19, that will address the immediate need for preventive interventions, generate key data on COVID-19 transmission, and serve as a research platform for future vaccines and preventive agents.
NCT04321174 Coronavirus Infections Post-exposure Prophylaxis Drug: Lopinavir/ritonavir MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome
Primary Outcomes
Description: The primary outcome is microbiologically confirmed COVID-19 infection, ie. detection of viral RNA in a respiratory specimen (mid-turbinate swab, nasopharyngeal swab, sputum specimen, saliva specimen, oral swab, endotracheal aspirate, bronchoalveolar lavage specimen) by day 14 of the study.
Measure: Microbiologic evidence of infection Time: 14 daysSecondary Outcomes
Description: a) Adverse events: as defined using the DAIDS Table for Grading the Severity of Adverse Events, at 7, 14, 28 & 90 days
Measure: Adverse events Time: 90 daysDescription: fever, cough or other respiratory/ systemic symptoms (including but not limited to fatigue, myalgias, arthralgias, shortness of breath, sore throat, headache, chills, coryza, nausea, vomiting, diarrhea) by day 14 in a patient with laboratory confirmed infection, combined with microbiologic confirmation of COVID-19 infection in the participant.
Measure: Symptomatic COVID-19 disease Time: 14 daysDescription: Reactive serology to SARS-CoV-2
Measure: Seropositivity Time: 28 daysDescription: The number of days (or partial days) spent admitted to an acute care hospital will be tabulated both at day 28 and day 90
Measure: Days of hospitalization attributable to COVID-19 disease Time: 90 daysDescription: The number of days (or partial days) requiring i) non-invasive and ii) endotracheal intubation with ventilation will be tabulated both at day 28 and day 90.
Measure: Respiratory failure requiring ventilatory support attributable to COVID-19 disease Time: 90 daysDescription: Death attributable to COVID-19 disease and all-cause mortality
Measure: Mortality Time: 90 daysDescription: Short-term psychological distress will be measured using the K10, with a standard cutoff score of ≥16.
Measure: Short-term psychological impact of exposure to COVID-19 disease Time: 28 daysDescription: Long-term impact will be measured at day 90 using the Impact of Event Scale, a validated measure of traumatic stress response, using a standard cutoff score of ≥26
Measure: Long-term psychological impact of exposure to COVID-19 disease Time: 90 daysDescription: Health-related quality of life will be measured using the EQ-5D-5L (EuroQol-5D). The EQ-5D consists of two pages: the EQ-5D descriptive system and the EQ visual analogue scale (EQ VAS). The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The tool will be administered to participants at 1, 14, 28 and 90 days.
Measure: Health-related quality of life Time: 90 days7 Treatment of Moderate to Severe Coronavirus Disease (COVID-19) in Hospitalized Patients
Investigational medications adjunct to clinical standard of care treatment will be assessed to evaluate safety and effectiveness as an anti-COVID-19 treatment. All hospitalized persons with moderate to severe COVID-19 disease that meet eligibility criteria will be offered participation.
NCT04321993 COVID-19 Drug: Lopinavir/ritonavir Drug: Hydroxychloroquine sulfate Drug: Baricitinib (janus kinase inhibitor) MeSH:Coronavirus Infections
Primary Outcomes
Description: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.
Measure: Clinical status of subject at day 15 (on a 7 point ordinal scale). Time: Up to 15 daysSecondary Outcomes
Description: Not hospitalized, no limitations on activities Not hospitalized, limitation on activities; Hospitalized, not requiring supplemental oxygen; Hospitalized, requiring supplemental oxygen; Hospitalized, on non-invasive ventilation or high flow oxygen devices; Hospitalized, on invasive mechanical ventilation or ECMO; Death.
Measure: Status on an ordinal scale assessed daily while hospitalized and on days 15 and 29 and 180. Time: Up to 180 daysDescription: Time to clinical improvement is defined as the time to normalization of respiratory rate, fever, and oxygen saturation, and alleviation of cough within 72 hours.
Measure: Length of time to clinical improvement Time: Up to 29 daysMeasure: Number of participants with normal pulmonary function and normal O2 saturation on days 11, 15 and 29 Time: Up to 29 days
Measure: Number of participants that developed Acute Respiratory Distress Syndrome (ARDS) after treatment Time: Up to 24 weeks
Description: Time to clinical progression, defined as the time to death, mechanical ventilation, or ICU admission
Measure: Length of time to clinical progression Time: Up to 29 daysMeasure: Cause of death (if applicable) Time: Up to 24 weeks
Measure: Sequential Organ Failure Assessment (SOFA) score, daily while hospitalized and on days 15 and 29. (Initial, highest, deltas and mean) Time: Up to 29 days
Description: Fever normalization as defined by: Temperature < 36.6 °C armpit, < 37.2 °C oral, or < 37.8 °C rectal sustained for minimum 24 hours
Measure: Length of time to normalization of fever Time: Up to 29 daysDescription: Oxygen normalization as defined by: peripheral capillary oxygen saturation (Sp02) > 94% sustained minimum 24 hours.
Measure: Length of time to normalization of oxygen saturation Time: Up to 29 daysMeasure: Duration of supplemental oxygen (if applicable) Time: Up to 29 days
Measure: Duration of mechanical ventilation (if applicable) Time: Up to 29 days
Measure: Duration of hospitalization Time: Up to 29 days
Measure: Adverse events Time: Up to 180 days
Other Outcomes
Measure: Global and SARS-CoV-2-specific immune responses before, during and after intervention and in standard of care treatment arm Time: Up to 180 daysMeasure: Percent of subjects with SARS-CoV-2 detectable in blood at days 3, 5, 8, 11, 15, 29 and 180. Time: Up to 180 days
Measure: Quantitative SARS-CoV-2 viral load in blood at days 3, 5, 8, and 11, 15, 29, and 180. Time: Up to 180 days
8 A Multi-centre, Adaptive, Randomized, Open-label, Controlled Clinical Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Patients (CATCO: Canadian Treatments for COVID-19), in Conjunction With the Public Health Emergency SOLIDARITY Trial (World Health Organization)
This study is an adaptive, randomized, open-label, controlled clinical trial, in collaboration with countries around the world through the World Health Organization. Subjects will be randomized to receive either standard-of-care products or the study medication plus standard of care, while being hospitalized for COVID-19. Participants will be randomized to one of the following groups: 1. Lopinavir/ritonavir 400mg/100mg PO BID for 14 day plus optimized supportive care, OR 2. Hydroxychloroquine 800mg BID for 1 day then 400mg BID for 10 days plus optimized supportive care, OR 3. Remdesivir 200mg IV on day 1, followed by 100 mg IV daily infusion for 9 days plus optimized supportive care, OR 4. Optimized support care all or until discharge from hospital, whichever occurs first
NCT04330690 COVID-19 Drug: Lopinavir/ritonavir Drug: Hydroxychloroquine Drug: remdesivir
Primary Outcomes
Description: All-cause mortality, assessed at hospital discharge.
Measure: Efficacy of Interventions Time: 29 daysSecondary Outcomes
Description: Measure with Ordinal Scale the time it takes for subject improvement
Measure: Time to improvement of one category from admission Time: up to 60 daysDescription: Subject clinical status at days 3, 5, 8, 11, 15, 29, 60 measured using the ordinal scale below: The scale is as below 0: Uninfected, no viral RNA Asymptomatic, viral RNA detected Symptomatic, independent Symptomatic, Assistance Needed Hospitalized: no oxygen therapy Hospitalized, on oxygen Hospitalized, Oxygen by NIV or high-flow Mechanical ventilation, p/f>150 or s/f >200 Mechanical ventilation, p/f<150 or s/f<200 OR vasopressors mechanical ventilation, p/f<150 AND vasopressors, dialysis, or ECMO death
Measure: Subject clinical status Time: up to 60 daysDescription: Mean change in the ranking from baseline to days 3, 5, 8, 11, 15, 29, 60 using the ordinal scale below: The scale is as below 0: Uninfected, no viral RNA Asymptomatic, viral RNA detected Symptomatic, independent Symptomatic, Assistance Needed Hospitalized: no oxygen therapy Hospitalized, on oxygen Hospitalized, Oxygen by NIV or high-flow Mechanical ventilation, p/f>150 or s/f >200 Mechanical ventilation, p/f<150 or s/f<200 OR vasopressors mechanical ventilation, p/f<150 AND vasopressors, dialysis, or ECMO death
Measure: Change in Subject clinical status Time: up to 60 daysDescription: the number of oxygen free days experienced
Measure: Oxygen free days Time: up to 29 daysDescription: if the subject required oxygen during hospitalization
Measure: Incidence of oxygen use Time: up to 29 daysDescription: if the subject required oxygen, for how long was it required
Measure: Duration of oxygen use Time: up to 29 daysDescription: if the subject required mechanical ventilation during hospitalization
Measure: Incidence of new mechanical ventilation Time: up to 29 daysDescription: if the subject required mechanical ventilation, for how long was it required
Measure: Duration of mechanical ventilation Time: up to 29 daysDescription: the length of hospitalization required
Measure: Duration of hospitalization Time: up to 29 daysDescription: Mortality rates calculated at day 15, 29, and 60.
Measure: Mortality Time: up to 60 daysDescription: The safety of the intervention will be evaluated during the trial period as compared to the control arm as assessed by the cumulative incidence of Grade 3 and 4 AEs and SAEs using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Paediatric Adverse Events, version 2.1 (July 2017).
Measure: Cumulative Incidence of Grade 3 and 4 Adverse Events (AEs) and Serious Adverse Events (SAEs) Time: up to 30 days after last dose of drug adminstrationOther Outcomes
Description: To evaluate the virologic efficacy of lopinavir/ritonavir, hydroxychloroquine, or remdesivir as compared to the control arm as assessed by the percent of subjects with SARS-CoV-2 detectable in OP sample at days 3, 5, 8, 11, 15, and 29
Measure: Time to viral clearance of lopinavir/ritonavir as compared to the control arm Time: up to 29 days9 Prospective, Phase II, Randomized, Open-label, Parallel Group Study to Evaluate the Efficacy of Hydroxychloroquine Together With Baricitinib, Imatinib or Early Lopinavir / Ritonavir in Patients With SARS Cov2 Pneumonia
In absence of vaccine and medications specifically designed to treat SARS-CoV-2 disease, identifying treatment options is critical at this time to control the disease outbreak. For this, we have designed a phase II trial of efficacy and safety with 3 branches of different combinations of treatment to identify which is the best early treatment option for patients with pneumonia due to SARS-CoV-2 (Covid-19) Identifying treatment options as early as possible is critical to the SARS-CoV-2 outbreak response. Currently, there is no approved vaccine for the disease and the treatments being used are not specifically designed for the SARS-CoV-2 virus, but are different groups of drugs used for other pathologies with mechanisms of action that justify their use because they inhibit entry of the virus into virus cells or proteases. The study aims to compare lopinavir / ritonavir (200 /50), imatinib 400mg, baricitinib 4mg, in combination with hydroxychloroquine 200mg, administered for 7 days in the setting of SARS-CoV-2 pneumonia treatment. Patients who meet inclusion criteria and do not have any exclusion criteria will be randomized to receive open treatment 1:1:1
NCT04346147 COVID-19 Pneumonia Drug: Hidroxicloroquine Drug: Lopinavir/ritonavir Drug: Imatinib tablets Drug: Baricitinib Oral Tablet MeSH:Pneumonia
HPO:Pneumonia
Primary Outcomes
Description: time from inclusion to improvement by 2 points on the "seven-category ordinal scale" or high, whichever comes first
Measure: time to clinical improvement Time: baseline to day 14
Secondary Outcomes
Description: number of serious adverse effects and premature discontinuation of treatment
Measure: Safety of treatments Time: through study completion, an average of 1 month
Description: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Measure: Tolerability of treatments Time: during treatment and up to 30 days after the last treatment dose
Other Outcomes
Description: Possible biomarkers and genetic markers of susceptibility to SARS-CoV-2 using high-performance techniques with serum DNA from the participants
Measure: Biomarkers and genetic markers of susceptibility to SARS-CoV-2 Time: baseline
10 Efficacy of Pragmatic Same-day Ring COVID-19 Prophylaxis for Adult Individuals Exposed to SARS-CoV-2 in Switzerland: an Open-label Cluster Randomized Trial
Primary Outcomes
Description: time from inclusion to improvement by 2 points on the "seven-category ordinal scale" or high, whichever comes first
Measure: time to clinical improvement Time: baseline to day 14Secondary Outcomes
Description: number of serious adverse effects and premature discontinuation of treatment
Measure: Safety of treatments Time: through study completion, an average of 1 monthDescription: Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE v5.0
Measure: Tolerability of treatments Time: during treatment and up to 30 days after the last treatment doseOther Outcomes
Description: Possible biomarkers and genetic markers of susceptibility to SARS-CoV-2 using high-performance techniques with serum DNA from the participants
Measure: Biomarkers and genetic markers of susceptibility to SARS-CoV-2 Time: baselineA study to assess, in a three-arm open-label cluster randomized clinical trial, the efficacy of a single-dose of HCQ treatment and of a 5-day course of LPV/r treatment in preventing COVID-19 in asymptomatic individuals exposed to a SARS-CoV-2 documented index patient, compared to surveillance alone.
NCT04364022 Prevention of COVID-19 Drug: Hydroxychloroquine Sulfate 200 MG [Plaquenil] Drug: Lopinavir/ritonavir
Primary Outcomes
Measure: 21-day incidence of COVID-19 in individuals exposed to SARS-CoV- 2 who are asymptomatic at baseline (intent-to-treat (ITT) analysis). Time: 21-daySecondary Outcomes
Measure: 21-day incidence of COVID-19 in individuals exposed to SARS-CoV- 2 who are asymptomatic, PCR-confirmed SARS-CoV-2 negative and have negative SARS-CoV-2 serology at baseline (modified ITT) Time: 21-dayMeasure: 21-day incidence of SARS-CoV-2 infection in individuals exposed to SARS-CoV-2 who are asymptomatic, PCR-confirmed SARS-CoV-2 negative and have negative SARS-CoV-2 serology at baseline (modified ITT) Time: 21-day
Description: (1: not hospitalized, no limitations on activities, 2: not hospitalized, limitation on activities, 3: hospitalized, not requiring supplemental oxygen, 4: hospitalized, requiring supplemental oxygen, 5: hospitalized, on non- invasive mechanical ventilation 6: hospitalized, on invasive mechanical ventilation or ECMO and 7: death)
Measure: Severity of clinical COVID-19 on a 7-point ordinal scale Time: 21-day