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

Conditions

1. Community-acquired Pneumonia, Influenza, COVID-19

Interventions

1. Drug: Fixed-duration Hydrocortisone
2. Drug: Shock-dependent hydrocortisone
3. Drug: Ceftriaxone
4. Drug: Moxifloxacin or Levofloxacin
5. Drug: Piperacillin-tazobactam
6. Drug: Ceftaroline
7. Drug: Amoxicillin-clavulanate
8. Drug: Macrolide administered for 3-5 days
9. Drug: Macrolide administered for up to 14 days
10. Drug: Five-days oseltamivir
11. Drug: Ten-days oseltamivir
12. Drug: Lopinavir/ritonavir
13. Drug: Hydroxychloroquine
14. Drug: Hydroxychloroquine + lopinavir/ritonavir
15. Drug: Interferon-β1a
16. Drug: Anakinra
17. Drug: Fixed-duration higher dose Hydrocortisone
18. Drug: Tocilizumab
19. Drug: Sarilumab
20. Drug: Vitamin C
21. Drug: Therapeutic anticoagulation
22. Drug: Simvastatin
23. Biological: Convalescent plasma
24. Other: Protocolised mechanical ventilation strategy
25. Drug: Eritoran
26. Drug: Apremilast
27. Drug: Aspirin
28. Drug: Clopidogrel
29. Drug: Prasugrel
30. Drug: Ticagrelor

MeSH:Pneumonia

HPO:Pneumonia

The study aims to evaluate the efficacy and safety of hydroxychloroquine in the treatment of COVID-19 pneumonia.

NCT04261517

Conditions

1. Pneumonia, Pneumocystis
2. Coronavirus
3. COVID-19

Interventions

1. Drug: Hydroxychloroquine

MeSH:Pneumonia, Pneumocystis Pneumonia

HPO:Pneumonia

Study Objective: 1. To test if post-exposure prophylaxis with hydroxychloroquine can prevent symptomatic COVID-19 disease after known exposure to the SARS-CoV-2 coronavirus. 2. To test if early preemptive hydroxychloroquine therapy can prevent disease progression in persons with known symptomatic COVID-19 disease, decreasing hospitalizations and symptom severity.

NCT04308668

Conditions

1. Corona Virus Infection
2. Acute Respiratory Distress Syndrome
3. SARS-CoV Infection
4. Coronavirus
5. Coronavirus Infections

Interventions

1. Drug: Hydroxychloroquine
2. Other: Placebo

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Double blinded randomized clinical trial designed to evaluate the security and efficacy of hydroxychloroquine as treatment for COVID-19 severe respiratory disease. The investigators hypothesize that a 400mg per day dose of hydroxychloroquine for 10 days will reduce all-cause hospital mortality in patients with severe respiratory COVID-19 disease.

NCT04315896

Conditions

1. COVID-19
2. Severe Acute Respiratory Syndrome

Interventions

1. Drug: Hydroxychloroquine
2. Drug: Placebo oral tablet

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

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

Conditions

1. Corona Virus Infection

Interventions

1. Drug: Remdesivir
2. Drug: Lopinavir/ritonavir
3. Drug: Interferon Beta-1A
4. Drug: Hydroxychloroquine
5. Other: Standard of care

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

Triple blinded, phase III randomized controlled trial with parallel groups (200mg of hydroxychloroquine per day vs. placebo) aiming to prove hydroxychloroquine's security and efficacy as prophylaxis treatment for healthcare personnel exposed to COVID-19 patients.

NCT04318015

Conditions

1. COVID-19
2. Severe Acute Respiratory Syndrome

Interventions

1. Drug: Hydroxychloroquine
2. Drug: Placebo oral tablet

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

The purpose of this study is to test the hypothesis that post-exposure prophylaxis with hydroxychloroquine will reduce the symptomatic secondary attack rate among household contacts of known or suspected COVID-19 patients.

NCT04318444

Conditions

1. COVID-19
2. Corona Virus Infection

Interventions

1. Drug: Hydroxychloroquine
2. Drug: Placebo oral tablet

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Around 20% of those infected have severe pneumonia and currently there is no specific or effective therapy to treat this disease. Therapeutic options using malaria drugs chloroquine and hydroxychloroquine have shown promising results in vitro and in vivo test. But those efforts have not involved large, carefully-conducted controlled studies that would provide the global medical community the proof that these drugs work on a significant scale. In this way, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with pneumonia by SARS-CoV2 virus.

NCT04321278

Conditions

1. Coronavirus Infections
2. Pneumonia, Viral

Interventions

1. Drug: Hydroxychloroquine + azithromycin
2. Drug: Hydroxychloroquine

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia

HPO:Pneumonia

The (World Health Organization) WHO NOR- (Coronavirus infectious disease) COVID 19 study is a multi-centre, adaptive, randomized, open clinical trial to evaluate the safety and efficacy of hydroxychloroquine, remdesivir and standard of care in hospitalized adult patients diagnosed with COVID-19. This trial will follow the core WHO protocol but has additional efficacy, safety and explorative endpoints.

NCT04321616

Conditions

1. SARS-CoV Infection
2. COVID 19
3. Acute Respiratory Distress Syndrome ARDS

Interventions

1. Drug: Hydroxychloroquine
2. Drug: Remdesivir
3. Other: (Standard of Care) SoC

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

This study explores whether patients acutely hospitalized may have shorter hospitalization and fewer admittances at Intensive Care Units by treatment with azithromycin and hydroxychloroquine.

NCT04322396

Conditions

1. Virus Diseases
2. Infection Viral
3. Corona Virus Infection

Interventions

1. Drug: Azithromycin
2. Drug: Hydroxychloroquine
3. Drug: Placebo oral tablet
4. Drug: Placebo oral tablet

MeSH:Infection Communicable Diseases Virus Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

This is a multi-center, randomized controlled, superiority, open label trial. The objective of this trial is to evaluate the efficacy of HCQ in patients with newly diagnosed COVID-19 who have mild to moderate disease or at risk for complications. We aim to demonstrate decrease in progression to severe pneumonia and hospital related complications among patients who are treated with HCQ compared to patients who are not.

NCT04323631

Conditions

1. COVID-19

Interventions

1. Drug: Hydroxychloroquine
2. Other: The control group will not receive hydroxychloroquine

MeSH:Infection Disease Progression

A new human coronavirus responsible for pneumonia, SARS-CoV-2, emerged in China in December 2019 and has spread rapidly. COVID-19, the disease caused by this virus, has a very polymorphous clinical presentation, which ranges from upper respiratory tract infections to acute respiratory distress syndrome. It may appear serious straightaway or may evolve in two stages, with a worsening 7 to 10 days after the first clinical signs, potentially linked to a cytokine storm and accompanied by a high risk of thrombosis. The global mortality rate of COVID-19 is between 3% and 4%, with severe forms being more frequent among older patients. Management is symptomatic as no antiviral treatment has demonstrated any clinical benefit in this condition. Hydroxychloroquine is a derivative of chloroquine commonly used in some autoimmune diseases, such as systemic lupus erythematosus. It is active in vitro in cellular models of infection by many viruses such as HIV, hepatitis C or SARS-CoV. However, its interest in viral infections in humans has not been demonstrated. Very recently, a preliminary uncontrolled study evaluated the effect of hydroxychloroquine on viral shedding in subjects with COVID-19. Among 20 patients treated with hydroxychloroquine at a dose of 600 mg per day, the percentage of patients with detectable SARS-CoV-2 RNA in the nasopharynx decreased from 100% at inclusion (start of treatment) to 43% six days later. In comparison, 15 of 16 untreated patients had a positive RT-PCR six days after inclusion. Furthermore, hydroxychloroquine has immunomodulating and anti-inflammatory properties, which could theoretically prevent or limit secondary worsening. The research hypothesis is that treatment with hydroxychloroquine improves prognosis and reduces the risk of death or use for invasive ventilation in patients with COVID-19.

NCT04325893

Conditions

1. Coronavirus

Interventions

1. Drug: Hydroxychloroquine
2. Drug: Placebo

MeSH:Coronavirus Infections

Since December 2019, the emergence of a new coronavirus named SARS-Cov-2 in the city of Wuhan in China has been responsible for a major epidemic of respiratory infections, including severe pneumonia. Within weeks, COVID-19 became a pandemic. In the absence of specific antiviral treatment, a special attention should be given to prevention. Personal protection equipments may be insufficiently protective, including in healthcare workers, a significant proportion of whom (around 4%) having been infected in the outbreaks described in China and more recently in Italy. Infection in healthcare workers could result from the contact with COVID-19 people in community or with infected colleagues or patients. As it will take at least a year before vaccines against SARS-CoV-2 becomes available, chemoprophylaxis is an option that should be considered in this setting where prevention of SARS-CoV-2 infection in Health Care Workers. The COVIDAXIS trial evaluates a chemoprophylaxis of SARS-CoV-2 infection in Health Care Workers. This trial is divided into two distinct studies that could start independently each with its own randomization process: COVIDAXIS 1 will study Hydroxychloroquine (HCQ) versus placebo; COVIDAXIS 2 will study Lopinavir/ritonavir (LPV/r) versus placebo. Upon randomization healthcare workers (HCWs) involved in the management of suspected or confirmed COVID-19 cases will be assigned to one of the following 2 treatment groups:

NCT04328285

Conditions

1. COVID-19

Interventions

1. Drug: Hydroxychloroquine
2. Drug: Placebo of Hydroxychloroquine
3. Drug: Lopinavir and ritonavir
4. Drug: Placebo of LPV/r Tablets

MeSH:Infection

Objective: To determine if pre-exposure prophylaxis with hydroxychloroquine is effective for the prevention of COVID-19 disease.

NCT04328467

Conditions

1. COVID-19
2. Corona Virus Infection
3. ARDS
4. Acute Respiratory Distress Syndrome

Interventions

1. Drug: Hydroxychloroquine
2. Other: Placebo

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Albertans with COVID-19 are at risk of deteriorating and developing severe illness. Those over age 40 or with co-morbid illness, and likely those who are immune suppressed, are at highest risk. This study will include a focus on people with immune-suppressed states. Individuals confirmed to have SARS-CoV-2 infection will be identified using administrative data (positive lab result, age 18 or over, not hospitalized, and not living in SL4 level of care). They will then be contacted by AHS staff, independent of the researchers, to obtain their consent for the researchers to contact them about this trial. The AHS staff member who contacts the individual will enroll consenting individuals into a study database. If they provided an email address an email will automatically be sent to the individual with study information. Those who decline to be contacted will also be informed of the study website so they can choose to review the study information and self-enrol, although they will need to do so quickly to meet study timelines. Enrolled participants will be contacted by a study coordinator. Those without access to the internet will be informed about the study details when they are contacted by a study coordinator. When the study coordinator contacts potential participants the study will be reviewed, and the potential participant will have an opportunity to ask questions. Consent for participation will be obtained by telephone. Telephone consent will be recorded. Participants will then be screened for inclusion and exclusion criteria by telephone interview and review of Alberta Netcare. Alberta Netcare is the province of Alberta's public Electronic Health Record used to store patient information so that it is easily accessible to healthcare professionals for the purpose of care. Information like immunizations, ECG results, diagnostic images and reports, written medical reports (e.g. surgery reports, consultations, hospital admissions), diagnostic lab testing results (e.g. blood tests, urine tests, blood bank info), allergies and intolerances (drug and food allergies, food intolerances), prescription history, and general patient information (e.g. name, birthdate, personal health number, address, phone number). Those who are not eligible for the study will be informed of the reason(s) for ineligibility (generally it will be a safety exclusion and they should be aware of this). Those who are eligible will be randomized to receive HCQ or placebo for a total duration of 5 days. Study drug will be delivered to their residence by courier. Telephone follow-up will occur at day 7 (range 7-10 days) and at day 30 (range 25-35 days).

NCT04329611

Conditions

1. COVID-19

Interventions

1. Drug: Hydroxychloroquine

This study will compare two drugs (hydroxychloroquine and azithromycin) to see if hydroxychloroquine is better than azithromycin in treating hospitalized patients with suspected or confirmed COVID-19.

NCT04329832

Conditions

1. COVID-19

Interventions

1. Drug: Hydroxychloroquine
2. Drug: Azithromycin

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

Conditions

1. COVID-19

Interventions

1. Drug: Lopinavir/ritonavir
2. Drug: Hydroxychloroquine
3. Drug: remdesivir