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Lopinavir/ritonavirWiki

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Clinical Trial MeSH HPO Drug Gene SNP Protein Mutation


Correlated Drug Terms (55)


Name (Synonyms) Correlation
drug1425 Macrolide administered for up to 14 days Wiki 0.32
drug1227 Interferon-β1a Wiki 0.32
drug1424 Macrolide administered for 3-5 days Wiki 0.32
drug1063 High-Titer COVID-19 Convalescent Plasma (HT-CCP) Wiki 0.32
drug949 Fixed-duration Hydrocortisone Wiki 0.32
drug1932 Protocolised mechanical ventilation strategy Wiki 0.32
drug1528 Multifrequency Bioimpedance Spectroscopy Wiki 0.32
drug2984 remdesivir Wiki 0.32
drug671 Corticosteroid injection Wiki 0.32
drug2254 Shock-dependent hydrocortisone Wiki 0.32
drug1125 Hydroxychloroquine sulfate Wiki 0.32
drug3043 ventilatory support with oxygen therapy Wiki 0.32
drug1092 Hydroxychloroquine + lopinavir/ritonavir Wiki 0.32
drug2423 TD139 Wiki 0.32
drug2308 Standard Plasma (FFP) Wiki 0.32
drug1820 Piperacillin-tazobactam Wiki 0.32
drug1052 Hidroxicloroquine Wiki 0.32
drug1371 Lopinavir/Ritonavir 400 mg/100 mg Wiki 0.32
drug156 Amoxicillin-clavulanate Wiki 0.32
drug2586 Ultra-Low-dose radiotherapy Wiki 0.32
drug1499 Mindfulness Rounds Wiki 0.32
drug1821 Piperacillin/tazobactam Wiki 0.32
drug1554 NIVOLUMAB Wiki 0.32
drug950 Fixed-duration higher dose Hydrocortisone Wiki 0.32
drug1533 MuscleSound Ultrasound Wiki 0.32
drug532 Ceftriaxone Wiki 0.32
drug1958 Q-NRG Metobolic Cart Device Wiki 0.32
drug946 Five-days oseltamivir Wiki 0.32
drug1523 Moxifloxacin or Levofloxacin Wiki 0.32
drug1180 Imatinib tablets Wiki 0.32
drug531 Ceftaroline Wiki 0.32
drug2472 Ten-days oseltamivir Wiki 0.32
drug2115 Routine standard of care Wiki 0.32
drug1386 Low molecular weight heparin Wiki 0.22
drug2499 Therapeutic anticoagulation Wiki 0.22
drug2263 Simvastatin Wiki 0.22
drug103 Abidol hydrochloride Wiki 0.22
drug2092 Ribavirin Wiki 0.22
drug1566 Nafamostat Mesilate Wiki 0.22
drug318 Baricitinib Oral Tablet Wiki 0.22
drug1108 Hydroxychloroquine Sulfate 200 MG [Plaquenil] Wiki 0.18
drug1220 Interferon Beta-1B Wiki 0.18
drug1219 Interferon Beta-1A Wiki 0.16
drug2197 Sarilumab Wiki 0.14
drug1706 Oseltamivir Wiki 0.13
drug1086 Hydroxychloroquine Wiki 0.13
drug2314 Standard care Wiki 0.12
drug159 Anakinra Wiki 0.12
drug2527 Tocilizumab Wiki 0.12
drug2662 Vitamin C Wiki 0.10
drug2067 Remdesivir Wiki 0.08
drug658 Convalescent plasma Wiki 0.08
drug2326 Standard of care Wiki 0.07
drug262 Azithromycin Wiki 0.05
drug1822 Placebo Wiki 0.02

Correlated MeSH Terms (6)


Name (Synonyms) Correlation
D011014 Pneumonia NIH 0.07
D003141 Communicable Diseases NIH 0.05
D007239 Infection NIH 0.05
D018352 Coronavirus Infections NIH 0.05
D045169 Severe Acute Respiratory Syndrome NIH 0.05
D011024 Pneumonia, Viral NIH 0.04

Correlated HPO Terms (1)


Name (Synonyms) Correlation
HP:0002090 Pneumonia HPO 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 of 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 Drug: Vitamin C Drug: Therapeutic anticoagulation Drug: Simvastatin Drug: Convalescent plasma Other: Protocolised mechanical ventilation strategy
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 not receiving organ support in 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.

At 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

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 month

Secondary Outcomes

Description: Time to negative saliva 2019-n-CoV RT-PCR

Measure: Time to negative saliva

Time: Up to 1 month

Description: Time to NEWS of 0

Measure: Time to clinical improvement

Time: Up to 1 month

Description: Length of hospitalisation

Measure: Hospitalisation

Time: Up to 1 month

Description: 30-day mortality

Measure: Mortality

Time: Up to 1 month

Description: Cytokine/ chemokine changes

Measure: Immune reaction

Time: up to 1 month

Description: Adverse events during treatment

Measure: Adverse events

Time: up to 1 month

Description: Time to negative NPS, saliva, urine and stool 2019-n-CoV RT-PCR

Measure: Time to negative all clinical specimens

Time: up to 1 month

4 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, 18

Secondary 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, 18

Description: 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 days

Description: Percentage of progression to supplemental oxygen requirement by day 7

Measure: Percentage of progression to supplemental oxygen requirement by day 7

Time: hospital day 7

Description: 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 7

Description: 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 days

Description: 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 7

Description: Safety and tolerability, as assessed by adverse effects

Measure: adverse effects

Time: up to 28 days

Description: Concentration of Lopinavir/ritonavir and hydroxychloroquine

Measure: Concentration of Lopinavir/ritonavir and hydroxychloroquine

Time: 1, 2, 4, 5, 12 hours after taking intervention medicine

5 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 (this treatment arm has been ceased since June 29, 2020) + Lopinavir/Ritonavir plus interferon ß-1a versus SoC (this treatment arm has been ceased since June 29, 2020) + Hydroxychloroquine (this treatment arm has been ceased since May 24, 2020). 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

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 15

Secondary Outcomes

Description: Time to an improvement of one category from admission on an ordinal scale. Time to an improvement of two categories from admission on an ordinal scale. Time to discharge (categories 1 or 2 of ordinal scale) from admission. 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 29

Description: • 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 29

Measure: 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 days

Description: Rate of mortality

Measure: Mortality

Time: In hospital, Day 28, Day 90

Measure: 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, 29

Measure: 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 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 hydroxychloroquine

Time: Days 1, 3, 5, 8 and 11

6 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 days

Secondary 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 days

Description: 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 days

Description: Reactive serology to SARS-CoV-2

Measure: Seropositivity

Time: 28 days

Description: 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 days

Description: 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 days

Description: Death attributable to COVID-19 disease and all-cause mortality

Measure: Mortality

Time: 90 days

Description: 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 days

Description: 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 days

Description: 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 days

7 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 as assessed by all-cause mortality

Time: 29 days

Secondary 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 days

Description: 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 days

Description: 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 days

Description: the number of oxygen free days experienced

Measure: Oxygen free days

Time: up to 29 days

Description: if the subject required oxygen during hospitalization

Measure: Incidence of oxygen use

Time: up to 29 days

Description: if the subject required oxygen, for how long was it required

Measure: Duration of oxygen use

Time: up to 29 days

Description: if the subject required mechanical ventilation during hospitalization

Measure: Incidence of new mechanical ventilation

Time: up to 29 days

Description: if the subject required mechanical ventilation, for how long was it required

Measure: Duration of mechanical ventilation

Time: up to 29 days

Description: the length of hospitalization required

Measure: Duration of hospitalization

Time: up to 29 days

Description: Mortality rates calculated at day 15, 29, and 60.

Measure: Mortality

Time: up to 60 days

Description: 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 adminstration

Other 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 days

8 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

9 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

A 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-day

Secondary 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-day

Measure: 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

10 Low Doses of Lung Radiation Therapy in Cases of COVID-19 Pneumonia: Prospective Multicentric Study in Radiation Oncology Centers

The host response against the coronavirus 2 (SARS-CoV-2) appears to be mediated by a 'cytoquine storm' developing a systemic inflammatory mechanism and an acute respiratory distress syndrome (ARDS), in the form of a bilateral pneumonitis, requiring invasive mechanical ventilation (IMV) in an important group of patients. In terms of preventing progression to the critical phase with the consequent need of admission to the intensive care units (ICU), it has been recently proposed that this inflammatory cytoquine-mediated process can be safely treated by a single course of ultra-low radiotherapy (RT) dose < 1 Gy. The main purpose of the study was to analyze the efficacy of ultra low-dose pulmonary RT, as an anti-inflammatory intention in patients with SARS-Cov-2 pneumonia with a poor or no response to standard medical treatment and without IMV.

NCT04394182 Pneumonia, Viral Cytokine Storm Radiation: Ultra-Low-dose radiotherapy Device: ventilatory support with oxygen therapy Drug: Lopinavir/ritonavir Drug: Hydroxychloroquine Drug: Azithromycin Drug: Piperacillin/tazobactam Drug: Low molecular weight heparin Drug: Corticosteroid injection Drug: Tocilizumab
MeSH:Pneumonia, Viral Pneu Pneumonia
HPO:Pneumonia

Primary Outcomes

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir >VMK >Nasal Cannula-(NC).)

Measure: Oxygen Therapy Status at Day 2

Time: At 2 after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)

Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 2

Time: At 2 days after RT

Secondary Outcomes

Description: Pa02 / Fi02 > 300 mmHg

Measure: Blood Gas Analysis at Day 2

Time: At 2 days after RT

Description: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)

Measure: Blood Test at Day 2

Time: At 2 days after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir >VMK >Nasal Cannula-(NC).)

Measure: Oxygen Therapy Status at Day 5

Time: At 5 after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)

Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 5

Time: At 5 days after RT

Description: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)

Measure: Blood Test at Day 5

Time: At 5 days after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation.It was performed by oxygen therapy status assessment after RT treatment. Improvement criteria is considered as an oxygen therapy de-escalation (more to less need for support: Ventimask (VMK) with reservoir >VMK >Nasal Cannula-(NC).)

Measure: Oxygen Therapy Status at Day 7

Time: At 7 after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through clinical evaluation. .It was performed by oxygen saturation (Sat02 %) status assessment after RT treatment. Improvement criteria is considered as a Sat02 with/without oxygen therapy >93% (Pulse oximeter measurement)

Measure: Oxygen Saturation (Sat02; Pulse oximeter measurement) at Day 7

Time: At 7 days after RT

Description: Achievement of normal range value in 1 or more of the inflammatory and immunological parameters (lymphocytes, IL-6, D-dimer, ferritin, LDH, C Reactive Protein (CRP) and fibrinogen)

Measure: Blood Test at Day 7

Time: At 7 days after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through radiological evaluation.It was performed by thoracic CT scan after RT treatment . It is considered a radiological improvement the decrease of the Total Severity Score (TSS) from the baseline in > or = 1 point. NOTE: The score values ranged from 0 to 4 according to the sum of the percentage involvement of each of the 5 lung lobes. The total severity score (TSS), was reached by summing the overall involvement in the lung (0-20 points)

Measure: Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan at Day 7

Time: At 7 days after RT

Description: Recovery time after RT administration until hospital discharge or death (<48h; 2-7 days; >7 days; clinical worsening or death)

Measure: Recovery time

Time: From RT administration until hospital discharge or death

Description: COVID-19 negativization test

Measure: COVID-19 status

Time: At 7 days after RT

Description: To evaluate the efficacy of ultra low-dose pulmonary RT through radiological evaluation.It was performed by thoracic CT scan after RT treatment . It is considered a radiological improvement the decrease of the Total Severity Score (TSS) from the baseline in > or = 1 point. NOTE: The score values ranged from 0 to 4 according to the sum of the percentage involvement of each of the 5 lung lobes. The total severity score (TSS), was reached by summing the overall involvement in the lung (0-20 points)

Measure: Change from baseline Total Severity Score (TSS) analyzed in a thoracic CT scan al Month 1

Time: At 1 month after RT

Description: Toxicity was assessed and rated according to the NIH Common Terminology Criteria for Adverse Events (CTCAE version 5.0) and RTOG scales.

Measure: Acute Toxicity

Time: 1-3 months after RT


Related HPO nodes (Using clinical trials)