There are 64 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

2 Efficacy and Safety of Hydroxychloroquine for Treatment of COVID-19

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

NCT04261517 Pneumonia, Pneumocystis Coronavirus COVID-19 Drug: Hydroxychloroquine

MeSH:Pneumonia, Pneumocystis Pneumonia

HPO:Pneumonia

3 Post-exposure Prophylaxis or Preemptive Therapy for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial

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 Corona Virus Infection Acute Respiratory Distress Syndrome SARS-CoV Infection Coronavirus Coronavirus Infections Drug: Hydroxychloroquine Other: Placebo

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

4 Hydroxychloroquine Treatment for Severe COVID-19 Respiratory Disease: Randomised Clinical Trial (HYDRA Trial)

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 COVID-19 Severe Acute Respiratory Syndrome Drug: Hydroxychloroquine Drug: Placebo oral tablet

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

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 + 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

6 Chemoprophylaxis With Hydroxychloroquine in Healthcare Personnel in Contact With COVID-19 Patients: A Randomized Controlled Trial (PHYDRA Trial)

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 COVID-19 Severe Acute Respiratory Syndrome Drug: Hydroxychloroquine Drug: Placebo oral tablet

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infect Coronavirus Infections

7 Hydroxychloroquine Post Exposure Prophylaxis (PEP) for Household Contacts of COVID-19 Patients: A NYC Community-Based Randomized Clinical Trial

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 COVID-19 Corona Virus Infection Drug: Hydroxychloroquine Drug: Placebo oral tablet

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases

8 Evaluation of the Safety and Clinical Efficacy of Hydroxychloroquine Associated With Azithromycin in Patients With Pneumonia Caused by Infection by the SARS-CoV2 Virus - Coalition COVID-19 Brasil II - Severely-ill Patients

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 Coronavirus Infections Pneumonia, Viral Drug: Hydroxychloroquine + azithromycin Drug: Hydroxychloroquine

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

HPO:Pneumonia

9 The (Norwegian) NOR Solidarity Multicenter Trial on the Efficacy of Different Anti-viral Drugs in SARS-CoV-2 Infected Patients

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 SARS-CoV Infection COVID 19 Acute Respiratory Distress Syndrome ARDS Drug: Hydroxychloroquine Drug: Remdesivir Other: (Standard of Care) SoC

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

10 Proactive Prophylaxis With Azithromycin and Chloroquine in Hospitalized Patients With COVID: A Randomized, Placebo-controlled Double-blinded Trial Evaluating Treatment With Azithromycin and Hydroxychloroquine to Patients With COVID-19

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 Virus Diseases Infection Viral Corona Virus Infection Drug: Azithromycin Drug: Hydroxychloroquine Drug: Placebo oral tablet Drug: Placebo oral tablet

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

11 Hydroxychloroquine Versus Placebo in Patients Presenting COVID-19 Infection and at Risk of Secondary Complication: a Prospective, Multicentre, Randomised, Double-blind Study

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 Coronavirus Drug: Hydroxychloroquine Drug: Placebo

MeSH:Coronavirus Infections

12 Chemoprophylaxis of SARS-CoV-2 Infection (COVID-19) in Exposed Healthcare Workers : A Randomized Double-blind Placebo-controlled Clinical Trial

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 COVID-19 Drug: Hydroxychloroquine Drug: Placebo of Hydroxychloroquine Drug: Lopinavir and ritonavir Drug: Placebo of LPV/r Tablets

MeSH:Infection

13 Pre-exposure Prophylaxis for SARS-Coronavirus-2: A Pragmatic Randomized Clinical Trial

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

NCT04328467 COVID-19 Corona Virus Infection ARDS Acute Respiratory Distress Syndrome Drug: Hydroxychloroquine Other: Placebo

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

14 A Randomized, Double-blind, Placebo-controlled Trial to Assess the Efficacy and Safety of Oral Hydroxychloroquine for the Treatment of SARS-CoV-2 Positive Patients for the Prevention of Severe COVID-19 Disease.

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 COVID-19 Drug: Hydroxychloroquine

15 A Trial of Ciclesonide Alone or in Combination With Hydroxychloroquine for Adults With Mild COVID-19

According to In vitro studies, ciclesonide showed good antiviral activity against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Although some cases were reported for the clinical effectiveness of ciclesonide in the treatment of COVID-19, there is no clinical trial to evaluate the antiviral effect on the reduction of viral load in patients with COVID-19. In this study, we aimed to investigate whether ciclesonide alone or in combination with hydroxychloroquine could eradicate SARS-CoV-2 from respiratory tract earlier in patients with mild COVID-19.

NCT04330586 COVID-19 Drug: Ciclesonide Metered Dose Inhaler [Alvesco] Drug: Hydroxychloroquine

16 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

17 Pre-Exposure Prophylaxis With Hydroxychloroquine for High-Risk Healthcare Workers During the COVID-19 Pandemic: A Unicentric, Double-Blinded Randomized Controlled Trial

The investigators aim to evaluate the efficacy of pre-exposure prophylaxis with hydroxychloroquine in healthcare workers with high-risk of SARS-CoV-2 infection.

NCT04331834 COVID-19 Drug: Hydroxychloroquine Drug: Placebos

18 Pilot, Randomized, Multicenter, Open-label Clinical Trial of Combined Use of Hydroxychloroquine, Azithromycin, and Tocilizumab for the Treatment of SARS-CoV-2 Infection (COVID-19)

COVID-19 is a respiratory disease caused by the new coronavirus (SARS-CoV-2) and causes considerable morbidity and mortality. Currently, there is no vaccine or therapeutic agent to prevent and treat a SARS-CoV-2 infection. This clinical trial is designed to evaluate the use of Tocilizumab in combination with hydroxychloroquine and azithromycin for the treatment of hospitalized adult patients with COVID-19.

NCT04332094 COVID-19 Drug: Tocilizumab Drug: Hydroxychloroquine Drug: Azithromycin

19 Convalescent Plasma for Patients With COVID-19: A Randomized, Open Label, Parallel, Controlled Clinical Study

Convalescent plasma (CP) has been used in recent years as an empirical treatment strategy when there is no vaccine or treatment available for infectious diseases. In the latest viral epidemics, such as the Ebola outbreak in West Africa in 2014, the World Health Organization issued a document outlining a protocol for the use of whole blood or plasma collected from patients who have recovered from the Ebola virus disease by transfusion to empirically treat local infectious outbreaks

NCT04332835 Coronavirus Coronavirus Infection Drug: Plasma Drug: Hydroxychloroquine

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

20 Outcomes Related to COVID-19 Treated With Hydroxychloroquine Among In-patients With Symptomatic Disease

ORCHID is a multicenter, blinded, placebo-controlled, randomized clinical trial evaluating hydroxychloroquine for the treatment of adults hospitalized with COVID-19. Patients, treating clinicians, and study personnel will all be blinded to study group assignment.

NCT04332991 Coronavirus Acute Respiratory Infection SARS-CoV Infection Drug: Hydroxychloroquine Drug: Placebo

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

HPO:Respiratory tract infection

21 A Prospective Clinical Study of Hydroxychloroquine in the Prevention of SARS- CoV-2 (COVID-19) Infection in Healthcare Workers After High-risk Exposures

In order to assess the efficacy of hydroxychloroquine treatment weekly for a total of 7 weeks in the prevention of COVID-19 infection, three hundred sixty (360) Healthcare workers with high risk exposure to patients infected with COVID-19 will be tested for COVID-19 infection via nasopharyngeal (NP) swab once weekly for 7 weeks. Of those, one hundred eighty (180) will receive weekly doses of hydroxychloroquine for the duration of the study. Subjects who opt not to receive the study drug will form the control group.

NCT04333225 COVID-19 Drug: Hydroxychloroquine

MeSH:Infection

22 Hydroxychloroquine vs. Azithromycin for Outpatients in Utah With COVID-19 (HyAzOUT): A Prospective Pragmatic Trial

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

NCT04334382 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin

23 Prevention of SARS-CoV-2 (COVID-19) Through Pre-Exposure Prophylaxis With Tenofovir Disoproxil Fumarate/Emtricitabine and Hydroxychloroquine in Healthcare Personnel: Randomized Clinical Trial Controlled With Placebo

Healthcare workers are particularly at risk of SARS-CoV-2. This study aims to assess the efficacy of a daily single dose of tenofovir disoproxil fumarate (TDF) (245 mg)/ Emtricitabine (FTC) (200 mg), a daily single dose of hydroxychloroquine (HC) (200 mg), a daily single dose of TDF (245 mg)/FTC (200 mg) plus HC (200 mg) versus placebo, during 12 weeks in: (1) reducing the incidence of symptomatic disease and (2) reducing clinical severity COVID-19 among hospital healthcare workers aged 18 to 70 years in public and private hospitals in Spain.

NCT04334928 Coronavirus Infection Drug: Emtricitabine/tenofovir disoproxil Drug: Hydroxychloroquine Drug: Placebo: Emtricitabine/tenofovir disoproxil Placebo Drug: Placebo: Hydroxychloroquine

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome

24 Randomized Study to Evaluate the Safety and Antiviral Efficacy of Hydroxychloroquine in Patients With Newly Diagnosed COVID-19 Compared to Standard of Care Treatment

This study will assess the efficacy of hydroxychloroquine in reducing the severity of symptoms in patients with COVID-19

NCT04334967 COVID-19 Corona Virus Infection SARS-CoV-2 2019-nCoV 2019 Novel Coronavirus Drug: Hydroxychloroquine Dietary Supplement: Vitamin C

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases

25 An Open Label Phase II Study of Hydroxychloroquine, Vitamin C, Vitamin D, and Zinc for the Prevention of COVID-19 Symptoms

This is a Phase II interventional study testing whether treatment with hydroxychloroquine, Vitamin C, Vitamin D, and Zinc can prevent symptoms of COVID-19

NCT04335084 COVID-19 Coronavirus Infection Sars-CoV2 Corona Virus Infection COVID Coronavirus Coronavirus-19 Coronavirus 19 Drug: Hydroxychloroquine Dietary Supplement: Vitamin C Dietary Supplement: Vitamin D Dietary Supplement: Zinc

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

26 Pragmatic Factorial Trial of Hydroxychloroquine, Azithromycin, or Both for Treatment of Severe SARS-CoV-2 Infection

This is a pragmatic, randomized, open-label, incomplete factorial with nested randomization clinical trial evaluating the efficacy and safety of two potential treatments for hospitalized patients with confirmed SARS-CoV-2 infection. Participants who are hospitalized and have a positive nucleic acid amplification test for SARS-CoV-2 will undergo an initial randomization in a 1:1 ratio to one of the following regimens: Arm 1: Standard of care alone Arm 2: Standard of care plus hydroxychloroquine Participants who meet eligibility criteria to receive azithromycin will undergo a second randomization in a 1:1 ratio to receive additional concurrent therapy. This will effectively result in four treatment groups: 1. Standard of care alone 2. Standard of care plus hydroxychloroquine 3. Standard of care plus azithromycin 4. Standard of care plus hydroxychloroquine plus azithromycin

NCT04335552 SARS-CoV-2 Other: Standard of care Drug: Hydroxychloroquine Drug: Azithromycin

MeSH:Infection

27 Low-dose Hydroxychloroquine for Primary Prophylaxis Against SARS-CoV-2 in Health-care Workers - a Randomized, Double-blind, Controlled Trial

Background: Aim: To demonstrate the efficacy of low-dose hydroxychloroquine as primary prevention in healthcare workers Design, participants and interventions: Prospective, randomized, parallel group, double-blinded, placebo controlled, study. including 440 participants who will be randomised to 2 treatment arms: hydroxychloroquine or placebo. Outcome variables: symptomatic or asymptomatic SARS-CoV-2 infection confirmed by PCR, viral load during SARS-CoV-2 infection, seroconversion during the study period, incidence of any acute respiratory infection, days of sick leave. Statistical considerations: No trials have been published investigating the efficacy of HCQ as primary prophylaxis of SARS-CoV-2 infection in health care workers. Thus, sample size calculations in the proposed trial are based on the investigators' best estimates for several parameters. In accordance to the effect of oseltamivir against symptomatic influenza, we assumed an approximate effectiveness of approximately 60% (HR of 0.4) (https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6464969/) as realistic. As a prophylactic intervention with HCQ, which may have side effects and for which supply shortage can be expected, was judged justifiable only if its effectiveness is high, we based our sample size consideration on a HR of 0.3. To estimate the probability of an event in both the experimental and the control group, very little data is available. In a Dutch point-prevalence study 0-10% of health-care workers were infected depending on the healthcare institution, depending on the hospital. This point-prevalence study was performed between 6 and 9 March, when the reported number of cases in the Netherlands was 33 and 77, respectively, according to the RIVM (https://www.rivm.nl/nieuws/resultaat-steekproef-4-ziekenhuismedewerkers-heeft-coronavirus). Additionally, in an a report published in the Lancet, 20% of responding healthcare workers in Italy were found to be infected with SARS-CoV2 within less than one month (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)30627-9/fulltext). Several media reports indicate that this proportion is similar across various healthcare institutions and countries (https://www.nytimes.com/2020/03/24/world/europe/coronavirus-europe-covid-19.html) and (https://www.aljazeera.com/news/2020/03/spain-tightens-restrictions-week-lockdown-begins-2003 30191539568.html). As the proposed study will be performed in a high-risk setting, we assumed an event (i.e. PCR positivity) probability of 10% in the control group and 3% in the experimental arm after the maximum study period. In summary, a sample size of 210 participants per arm is necessary to detect a HR of 0.3 with a power of 80.3% with an alpha-error of 0.05. To account for drop-outs and asymptomatic, undetected infection at inclusion or past infection with existing immunity, an additional 10 participants will randomized per treatment arm. The overall study population is therefore 440 participants. Statistical analysis will be based on two populations: A Modified Intention to Treat population excluding those who withdrew consent after randomization and those with a positive serology at baseline. And a per protocol population including all randomized subjects who completed at least 3 out of 4 follow-up visits and took at least 80% of all doses of study medication.

NCT04336748 Sars-CoV2 Infection Viral Healthcare Worker Prophylaxis Drug: Hydroxychloroquine

MeSH:Virus Diseases

28 Pakistan Randomized and Observational Trial to Evaluate Coronavirus Treatment

To evaluate the effectiveness of Hydroxychloroquine Phosphate/Sulfate (200 mg orally 8hr thrice a day for 5 days) vs oseltamivir (75 mg orally twice a day for 5 days) vs Azithromycin (500 mg orally daily on day 1, followed by 250 mg orally twice a day on days 2-5) alone and in combination (in all seven groups), in clearing the coronavirus nucleic acid from throat and nasal swab and in bringing about clinical improvement on day 7 of follow-up (primary outcomes).

NCT04338698 COVID 19 Drug: Hydroxychloroquine Drug: Oseltamivir Drug: Azithromycin

29 Evaluation of the Efficacy and Safety of Camostat Mesilate + Hydroxychloroquine Combination Therapy in Hospitalized Patients With Moderate COVID-19 Infection

Evaluation of the efficacy and safety of hydroxychloroquine - camostat combination therapy in hospitalized patients with moderate COVID-19 infection, CLOCC-Trial Primary Objectives: The primary objective of this study is to demonstrate, that a combination therapy of hydroxychloroquine and camostat (Foipan®) is superior to hydroxychloroquine + placebo in participants with moderate COVID-19.

NCT04338906 COVID Drug: Camostat Mesilate Drug: Placebo Drug: Hydroxychloroquine

30 Azithromycin Added to Hydrochloroquine in Patients Admitted to Intensive Care Due to Coronavirus Disease 2019 (COVID-19)- Randomised Controlled Trial

Trial design: Prospective, multi-centre, randomised, pragmatic, double blind trial Methods: Participants: Adult (>18 years) within 24 hours of admission to intensive care unit with proven or suspected COVID-19 infection, whether or not mechanically ventilated. Exclusion criteria: symptoms of febrile disease for ≥1 week, treatment limitations in place or moribund patients, allergy or intolerance of any study treatment, incl. long QT syndromes, participation in another outcome-based interventional trial within last 30 days, patients taking Hydrochloroquine for other indication than COVID-19, pregnancy. Interventions: Patients will be randomised in 1:1:1 ratio to receive Hydrochloroquine 800mg orally in two doses followed by 400mg daily in two doses and Azithromycin 500 mg orally in one dose followed by 250 mg in one dose for a total of 5 days (HC-A group) or Hydrochloroquine+ placebo (HC group) or placebo + placebo (C-group) in addition to best standard of care, which may evolve during the trial period but will not differ between groups. Objective: To test the hypothesis that early administration of combination therapy slows disease progression and improves mechanical-ventilation free survival. Outcomes: Primary outcome: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14. Secondary outcomes: Composite percentage of patients alive and not on end-of-life pathway who are free of mechanical ventilation at day 14 in the subgroup of patients without the need of mechanical ventilation at baseline. ICU-LOS D28 and D 90 mortality (in hospital) Tertiary (exploratory) outcomes: Viral load at D7 of study enrolment (No of viral RNA copies/ml of blood), proportion of patients alive and rtPCR negative from nasal swab at D14, Difference of FiO2 requirement and respiratory system compliance between day 0 and 7. Randomization: In 1:1:1 ratio and stratified according to study centre and patients age (cut-off 70 years) Blinding (masking): Patients, treating clinicians, outcome assessors and data analyst will be blinded to study treatment allocation. Unblinded study pharmacist or research nurse will prepare investigational products.

NCT04339816 COVID-19 Respiratory Failure Drug: Azithromycin Drug: Hydroxychloroquine Drug: Placebo

MeSH:Respiratory Insufficiency

31 Hydroxychloroquine for the Treatment of Mild COVID-19 Disease

The current outbreak of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome corona virus 2 (SARS-CoV-2) is a global health emergency with a case fatality rate so far approximately 4% and a growing number of confirmed cases (>57.000) in Germany. There is no data available on the efficacy of antiviral agents for the treatment of COVID-19. In-vitro data show that hydroxychloroquine can inhibit SARS-CoV-2 [1] replication and anecdotal reports from Chinese COVID-19 patients [2, 3] suggest that chloroquine is a good candidate for treatment. No data have been published and reported evidence is based on non-controlled use of hydroxychloroquine. The aim of this placebo-controlled trial is to assess the effect of hydroxychloroquine on duration of symptoms in mild COVID-19 patients and time of virus shedding as an important tool to reduce the risk of further community transmissions. This data will inform practice for the design of larger trials on clinical efficacy of hydroxychloroquine in the treatment and post- and preexposure prophylaxis of COVID-19 and as a tool for reduction of community transmission.

NCT04340544 COVID-19 Drug: Hydroxychloroquine Drug: Placebo

32 COVID 19 - Epidemiology of SARS-CoV-2 and Mortality to Covid19 Disease Upon Hydroxychloroquine and Azithromycin Therapy in French Cancer Patients

To determine the prevalence and the 3-months incidence of SARS-CoV-2 in cancer patients (Part A). To evaluate the Covid-19 disease-specific mortality rate in cancer patients treated by hydroxychloroquine and azithromycin (Part B).

NCT04341207 Cancer Cancer & Cancer & COVID 19 Drug: Hydroxychloroquine Drug: Azithromycin

33 Treatment With Hydroxychloroquine vs Nitazoxanide + Hydroxychloroquine in Patients With COVID-19 With Risk Factors for Poor Outcome

Coronaviruses (CoV) are positive-sense single-stranded RNA viruses that infect a wide range of hosts producing diseases ranging from the common cold to serious / fatal events. Nitazoxanide (NTZx) is a derivative of 5-nitrothiazole, synthesized in 1974 by Rosignol - Cavier. NTZx has powerful antiviral effects through the phosphorylation of protein kinase activated by double-stranded RNA, which leads to an increase in phosphorylated factor 2-alpha, an intracellular protein with antiviral effects. The purpose of this study is to contrast the beneficial effect of NTZx vs NTZx plus hydroxychloroquine in patients Coronavirus Disease (COVID-19) as well as against other treatments.

NCT04341493 Coronavirus Infection Drug: Nitazoxanide 500 MG Drug: Hydroxychloroquine

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

34 Efficacy of Sarilumab + Azithromycin + Hydroxychloroquine, and Sarilumab Alone, for Adult Patients Hospitalized With Moderate to Severe COVID-19: a Multicenter Open-label 1:1 Randomized Controlled Trial

The overall objective of the study is to determine the therapeutic effect and tolerance of Sarilumab in combination with Azithromycin and Hydroxychloroquine, compared to Sarilumab only, patients with moderate, severe pneumonia associated with Coronavirus disease 2019 (COVID-19). Sarilumab is a human IgG1 monoclonal antibody that binds specifically to both soluble and membrane-bound IL-6Rs (sIL-6Rα and mIL-6Rα) and has been shown to inhibit IL-6-mediated signaling through these receptors. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering investigational treatments administration to patients enrolled in the CORIMUNO-19 cohort (NCT04324047). Sarilumab+Azithromycin+Hydroxychloroquine, or Sarilumab only will be administered to consenting adult patients hospitalized with COVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation. All patients will receive standard of care along with randomized investigational treatments. Outcomes of included patients will be compared between groups as well as with outcomes of patients in the CORIMUNO-19 cohort treated with other immune modulators or standard of care.

NCT04341870 COVID19 SARS-CoV-2 Infection Drug: Sarilumab Drug: Azithromycin Drug: Hydroxychloroquine

35 Hydroxychloroquine for Outpatients With Confirmed COVID-19

A novel coronavirus, SARS-CoV-2, is responsible for a rapidly spreading pandemic that has reached 160 countries, infecting over 500,000 individuals and killing more than 24,000 people. SARS-CoV-2 causes an acute and potentially lethal respiratory illness, known as COVID-19, that is threatening to overwhelm health care systems due to a dramatic surge in hospitalized and critically ill patients. Patients hospitalized with COVID-19 typically have been symptomatic for 5-7 days prior to admission, indicating that there is a window during which an effective intervention could significantly alter the course of illness, lessen disease spread, and alleviate the stress on hospital resources. There is no known treatment for COVID-19, though in vitro and one poorly controlled study have identified a potential antiviral activity for HCQ. The rationale for this clinical trial is to measure the efficacy and safety of hydroxychloroquine for reducing viral load and shedding in adult outpatients with confirmed COVID-19.

NCT04342169 Coronavirus Infection Coronavirus Infectious Disease Drug: Hydroxychloroquine Drug: Placebo oral tablet

MeSH:Communicable Diseases Infection Coronavirus Infections Severe Acute Respiratory Syndrome

36 An Investigation Into Beneficial Effects of Interferon Beta 1a, Compared to Interferon Beta 1b And The Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized Clinical Trial

The present study is a randomized clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Loghman Hakim Medical Education Center in Tehran. Patients will be randomly assigned to the three arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

NCT04343768 COVID-19 Drug: Hydroxychloroquine Drug: Lopinavir / Ritonavir Drug: Interferon Beta-1A Drug: Interferon Beta-1B

37 Treatment in Patients With Suspected or Confirmed COVID-19 With Early Moderate or Severe Disease: A Randomized Clinical Trial

This study proposes to evaluate clinical outcomes and viral load in COVID-19 infected patients with early moderate and severe disease admitted to the hospital and randomized to one of three arms. Patients will be randomized to supportive care, OR hydroxychloroquine alone, OR hydroxychloroquine and azithromycin.

NCT04344444 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin

38 An Open-Label, Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects Positive With SARS-CoV-2 With Mild Symptoms

Currently there are no US Food and Drug Administration (FDA)-approved drugs specifically for the treatment of patients with COVID-19. At present, clinical management includes infection prevention and control measures, as well as supportive care, including supplementary oxygen and mechanical ventilatory support when indicated. An array of drugs approved for other indications as well as several investigational drugs are being studied in several hundred clinical trials that are underway across the globe; however, currently there are no clinical trials available to patients in Arizona. This study will determine if a specific drug cocktail can improve clinical outcomes in patients with confirmed Mild SARS-CoV-2

NCT04344457 COVID-19 Drug: Hydroxychloroquine Drug: Indomethacin Drug: Zithromax Oral Product

39 Efficacy and Safety of Novel Treatment Options for Adults With COVID-19 Pneumonia. A Double-blinded, Randomized, Multi-stage, 6-armed Placebo-controlled Trial in the Framework of an Adaptive Trial Platform

CCAP is an investigator-initiated multicentre, randomized, double blinded, placebo-controlled, multi-stage trial, which aims to assess the safety and efficacy of novel treatment option of moderate-severe COVID-19. Participants will be randomized 1:1:1:1:1:1 to parallel treatment arms: Convalescent plasma, sarilumab, hydroxychloroquine, baricitinib, intravenous and subcutaneous placebo, or oral placebo. Primary outcome is a composite endpoint of all-cause mortality or need of invasive mechanical ventilation up to 28 days.

NCT04345289 COVID Corona Virus Infection Viral Pneumonia Biological: Convalescent anti-SARS-CoV-2 plasma Drug: Sarilumab Drug: Baricitinib Drug: Hydroxychloroquine Other: Injective placebo Other: Oral placebo

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia, Viral Pneumonia Virus Diseases

HPO:Pneumonia

40 A Randomized, Controlled Clinical Trial of the Safety and Efficacy of Hydroxychloroquine for the Treatment of COVID-19 in Hospitalized Patients

This study is a randomized, open label clinical trial to evaluate the safety and efficacy of hydroxychloroquine (HCQ) plus usual care compared to usual care in approximately 350 hospitalized patients diagnosed with COVID-19. The study will be a 2-arm, non-blinded comparison between open label hydroxychloroquine and usual care. The course of treatment (HCQ) is five days. Participants will be followed to study day 28.

NCT04345692 COVID-19 Drug: Hydroxychloroquine

41 Immune Monitoring of Prophylactic Effect of Hydroxychloroquine in Healthcare Providers Highly Exposed to SARS-Cov-2

This is a PILOT STUDY, a Phase III double-blind, randomized, placebo-controlled clinical study in which we assess the clinical effect of the prophylactic administration of hydroxychloroquine vs. placebo to healthcare workers working at our University Hospital (HUN). Participants in each arm (n = 43) will be administered with a unique loading dose of 800 mg of hydroxychloroquine the first day followed by 400 mg/week for 90 days. The population to be studied (uninfected healthcare personnel) will be highly exposed to SARS-CoV-2 infection. An active search should be made for individuals who become infected while participating in the study, hence, once the informed consent form is signed, the molecular test for the diagnosis of SARS-CoV-2 infection by RT-PCR will be carried out every 4 days in order to determine as closely as possible the moment the participant becomes positive. The results of the diagnostic RT-qPCR tests will be confronted with: (i) the results of immune monitoring of at least 30 immunological parameters in leukocytes and in plasma (levels of selected cytokines and chemokines analyzed by automated flow cytometry software and (ii) the daily recording of data for the presence or absence of signs and symptoms associated with SARS-Cov-2 infection. For the recording of immune monitoring 20mL blood samples will be taken at eight-time points throughout the 90 days of the stud.

NCT04346329 COVID Drug: Hydroxychloroquine Drug: Placebo oral tablet

42 An Open Randomized Study of the Effectiveness of the Drug Mefloquine, Tablets 250 mg, Produced by FSUE SPC "Farmzashita" of the Federal Medical Biological Agency, FMBA of Russia (Russia) for the Treatment of Patients With COVID19

Study of the effectiveness and safety of the drug Mefloquine, tablets 250 mg, produced by FSUE "SPC" Farmzaschita " FMBA of Russia (Russia), in comparison with the drug Hydroxychloroquine, tablets 200 mg, for the treatment of patients with coronavirus infection, in the "off-label" mode, to make a decision on the possibility of expanding the indications for use.

NCT04347031 Pneumonia, Viral Respiratory Failure Drug: Mefloquine Drug: Hydroxychloroquine Combination Product: Mefloquine + azithromycin + / - tocilizumab Combination Product: Hydroxychloroquine + azithromycin + / - tocilizumab

MeSH:Pneumonia, Viral Pneumonia Respiratory Insufficiency

HPO:Pneumonia

43 EVALUATION OF THE EFFICACY OF THE HYDROXYCHLOROQUINE-AZITHROMYCIN COMBINATION IN THE IN THE PREVENTION OF COVID-19 RELATED SDRA

Since end of December, a new coronavirus, close to the 2002 SARS coronavirus, cause serious pneumonias throughout world. There is currently no strong evidence of an efficient specific treatment. Hydroxychloroquine is an old chloroquine-derived drug, prescribed for auto-immune disorders. It has shown efficacy against Sars-CoV-2 in vitro. Some studies showed that Hydroxychloroquine might improve the clinical status of Sars-CoV-2 infected patients. Azithromycin is a macrolide antibiotic, with immunomodulatory properties. Adding Azithromycin to a hydroxychloroquine-based treatment showed an apparent accelerated viral clearance in infected patients. This study wants to evaluate the clinical impact of adding Azithromycin to Hydroxychloroquine in the treatment of Sars-CoV-2 pneumonia

NCT04347512 Sars-CoV-2, Community-Acquired Pneumonia,COVID-19 Drug: Hydroxychloroquine and azithromycin treatment arm. Drug: Hydroxychloroquine Drug: Control arm

MeSH:Pneumonia

HPO:Pneumonia

44 Prophylactic Hydroxychloroquine vs Vitamin C in Healthcare Workers at Risk of COVID-19: A RCT

Healthcare workers (HCW) at risk of Covid-19 will have baseline serology for SARS-CoV-2 to see if they are already immune to Covid-19. HCW will get baseline assessment and if meeting inclusion criteria and no exclusion criteria they will be randomized in a 2:1 ratio to hydroxychloroquine or Vitamin C on a weekly basis for three months. Subjects will complete daily diary of symptoms and temperature, and will have repeat SARS-CoV-2 serology at 6 weeks and 3 months to determine seroconversion.

NCT04347889 Covid-19 Drug: Hydroxychloroquine Other: Vitamin C

45 The Randomized, Open, Phase 2 Study to Evaluate the Safety and Efficacy of Clevudine in Patients With Moderate COVID-19

The purpose of this clinical trial is to assess the safety and efficacy of Clevudine 120 mg once a day for 14 days (maximum up to 21 days) and of Hydroxychloroquine 200mg twice a day for 14 days (maximum up to 21 days) of administration in patients with moderate COVID-19.

NCT04347915 COVID-19 Drug: Clevudine Drug: Hydroxychloroquine

46 Dexamethasone Combined With Hydroxychloroquine Compared to Hydroxychloroquine Alone for Treatment of Severe Acute Respiratory Distress Syndrome Induced by Coronavirus Disease 19 (COVID-19): a Multicentre, Randomised Controlled Trial

Single blind randomized clinical trial designed to evaluate the efficacy of the combination of hydroxychloroquine and dexamethasone as treatment for severe Acute Respiratory Distress Syndrome (ARDS) related to coronavirus disease 19 (COVID-19). We hypothesize that dexamethasone (20 mg for 5 days followed by 10 mg for 5 days) combined with 600 mg per day dose of hydroxychloroquine for 10 days will reduce the 28-day mortality compared to hydroxychloroquine alone in patients with severe ARDS related COVID-19.

NCT04347980 Respiratory Distress Syndrome, Adult COVID-19 Drug: Dexamethasone and Hydroxychloroquine Drug: Hydroxychloroquine

MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury Syndrome

47 An Open-label Randomized Controlled Trial on Interferon β-1b and Hydroxychloroquine Combination Versus Hydroxychloroquine Alone, as Treatment for COVID-19 Infection

The novel coronavirus (SARS-CoV-2), is a single-stranded RNA coronavirus. The virus was first isolated from patients presented with pneumonia in Wuhan in December 2019. Sequences of the Wuhan betacoronavirus show similarities to betacoronaviruses found in bats, sharing a common ancestor with the 2003 SARS coronavirus (SARS-CoV) and the bat coronavirus HKU9, a virus found in fruit bats. Similar to SARS-CoV, it is a member of Beta-CoV lineage B. Five genomes of the novel coronavirus have been initially isolated and reported including BetaCoV/Wuhan/IVDC-HB-01/2019, BetaCoV/Wuhan/IVDC-HB-04/2020, BetaCoV/Wuhan/IVDC-HB-05/2019, BetaCoV/Wuhan/WIV04/2019, and BetaCoV/Wuhan/IPBCAMS-WH-01/2019 from the China CDC. The SARS-CoV-2 has since spread from China to the rest of the world. As of 5 April 2020, more than 1.05 million people been confirmed to have infected by SARS-CoV-2, resulting in more than 500,000 deaths. No specific antiviral treatment for the SARS-CoV-2 is currently available, but existing medication could be repurposed. Genetic sequencing demonstrated similarity of the SARS-CoV-2 to the SARS-CoV and MERS CoV.2 We expect patients infected with the SARS-CoV-2 will also present similarly with initial upper respiratory tract symptoms including fever, cough, sputum, myalgia and shortness or breath. More severe cases might complicate with pneumonia and required ventilatory or ECMO support. According to our previous studies in 2003 on patients hospitalized for severe SARS-CoV, the viral load peaked between day 7 from symptoms onset and coincided with clinical deterioration of pneumonia and respiratory failure, with majority of the patients required intensive care support. Higher viral load isolated from different human system also correlated with worsened SARS manifestation and complications. Previously, we have demonstrated that interferon-beta 1b, commonly used in the treatment of multiple sclerosis and lopinavir/ ritonavir, also demonstrated to improve the outcome of MERS-CoV infection in a non-human primate model of common marmoset. A non-randomized trial has also suggested that a combination of hydroxychloroquine and azithromycin might be effective in suppressing SARS-CoV-2 viral load in patients, despite in-vitro activity was only found in hydroxychloroquine. Therefore, we propose to conduct an open-label randomized controlled trial on a short course of interferon β-1b and hydroxychloroquine combination treatment for patients hospitalized for COVID-19 infection.

NCT04350281 COVID Drug: Interferon Beta-1B Drug: Hydroxychloroquine

48 Hydroxychloroquine Treatment of Healthcare Workers With COVID19 Illness at Montefiore: a Review of Process Feasibility, Safety, and Clinical Outcomes

Given the high prevalence of COVID19 illness (both SARS-CoV-2 RT-PCR confirmed and highly suspect cases) among healthcare workers (HCW) within the Montefiore Health System (MHS), hydroxychloroquine (HCQ) will be prescribed to healthcare workers who are at the highest risk for severe COVID19 illness.

NCT04350450 COVID Coronavirus COVID-19 Drug: Hydroxychloroquine

MeSH:Coronavirus Infections

49 High-dose Hydroxychloroquine for the Treatment of Ambulatory Patients With Mild COVID-19

This study aims to examine the tolerability of high dose hydroxychloroquine in patients with COVID-19 who are not yet hospitalized, but have risk factors for disease progression and complications.

NCT04351620 COVID-19 Drug: Hydroxychloroquine

50 A Randomized Phase 2/3 Trial of Hydroxychloroquine In Covid-19 Kinetics

To test if the medication Hydroxychloroquine will decrease the amount of virus(as measured by PCR) , 7 days after initiation of therapy compared to control patients receiving placebo. The study design is a randomized (5 days of medication v. 5 days of placebo) clinical trial initiated immediately after diagnosis in ambulatory health care workers at University of South Alabama Health, or in ambulatory USA patients. At 7 days after enrollment another nasopharyngeal swab will be taken to measure if the virus is still present. At 10 weeks we will measure immunity from Covid-19 using a single blood sample. It is a phase 2/3 clinical trial.

NCT04353271 Covid 19 Corona Virus Infection Drug: Hydroxychloroquine Other: Placebo

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases

51 Outpatient Treatment of Elderly People With Symptomatic SARS-CoV-2 Infection (COVID-19): a Multi-arm, Multi-stage (MAMS) Randomized Trial to Assess the Efficacy and Safety of Several Experimental Treatments to Decrease the Risk of Hospitalization or Death (COVERAGE Trial)

This trial will estimate the efficacy and tolerance of several experimental treatments to prevent hospitalization or death in outpatients aged 65 years or above with Symptomatic SARS-CoV-2 Infection (COVID-19).

NCT04356495 Corona Virus Infection Sars-CoV2 Dietary Supplement: Vitamins Drug: Hydroxychloroquine Drug: Imatinib Drug: Favipiravir Drug: Telmisartan

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

52 Effectiveness and Safety of Medical Treatment for SARS-CoV-2 (COVID-19) in Colombia: A Pragmatic Randomized Controlled Trial

Introduction: The COVID-19 pandemic is characterized by significant morbidity and mortality. It is caused by a novel coronavirus with no current specific prevention nor treatment therapies. Treatments have been administered to patients with COVID-19 in order to control viral infection, among them: Chloroquine (CQ) and Hydroxychloroquine (HCQ), Lopinavir/Ritonavir (Lop/r), Remdesivir, Favipavir, acting over bacterial co-infection Azithromycin (Azithro), or modifying the inflammatory response of the host (Tocilizumab). Clinical trials offer conflicting evidence regarding the effectiveness and safety of therapies The real effectiveness and safety profile of the treatments for COVID-19 remains unknown. Objective: Evaluate the effectiveness and safety of pharmacological therapies used to treat adult patients with COVID-19. Methods: Pragmatic randomized controlled trial. Study population: Adults aged 18 years or over with a positive real-time polymerase chain reaction (RT-PCR) for Severe Acute Respiratory Syndrome CoV-2 (SARS CoV-2) and diagnosis of mild, severe or critical pneumonia, requiring hospital management at six hospitals in Colombia. Exclusion criteria: Pregnancy, known allergy to treatment, cirrhosis or hepatic abnormality (transaminases greater than 5 reference values), prolonged QT interval, glomerular filtration rate lesser than 30 ml/min/1.73m^2, history of lung fibrosis, advanced or metastatic cancer. Sample size: 1,600 participants. The study will be carried out in two phases. The first phase will be conducted with 480 participants and aims to identify treatments with higher or minimum potential, discontinue treatments with higher toxicity and have opportunity of introducing new treatments with potential efficacy. The second phase will be conducted with 1,120 participants to evaluate the effectiveness of the selected treatments. Four interventions have been defined: I1 HCQ, I2 HCQ plus Lop/r, I3 HCQ plus Azithro and I4 standard treatment. Within each institution, participants will be randomly assigned to one of the treatment arms assigned to that institution. Concealment will be kept through a central telephone. Treatment administration will be open. Variables: Sociodemographic and clinical at recruitment; (comorbidities, need for therapeutic support , grade of invasion at admission). Primary outcomes. Effectiveness: Mortality. Safety: Serious adverse events (AE) assessed by the NCI Community Oncology Research Program (NCORP) Guidance for Collection of Adverse Events Related to COVID-19 Infection. Secondary outcomes: Intensive care unit (ICU) admission, requirement of respiratory support, time to death, number of participants cured, any adverse event related to treatment. Analysis: Descriptive for the presentation of summary measures of the basal conditions by type of variable. Bivariate. Description of the basal conditions (with organic failure at admission, without failure at admission), by type of treatment, by participating institution. Description of crude effectiveness and safety by means of the difference of accumulated incidences, each one with 95% confidence intervals (95% CI) Intention to treat analyisis will be done. Adjusted analysis: The ratio and difference of cumulative incidences of mortality at 7 and 28 days and severe adverse events between treatments will be estimated, adjusting for confounding variables using logistic regression models with mixed effects considering each institution as a level or from equations. generalized estimation (GEE). Ethical considerations: The study has a risk beyond minimum according to the Resolution 8430/1993 of the Colombian Ministry of Health. Informed consent will be explained and signed if the patient is in condition to do so. This protocol will undergo evaluation by the ethics committee at each of the participating institutions and at the National University of Colombia. The protocol follows the Helsinki Declaration and institutional protocols for clinical investigation.

NCT04359095 COVID-19 Drug: Hydroxychloroquine Drug: Lopinavir / Ritonavir Pill Drug: Azithromycin Other: Standard treatment

53 Efficacy and Safety of Azithromycin Compared to the Base Therapeutic Regiment of Hydroxychloroquine in Moderate to Severe COVID-19: A Randomized, Controlled, Double-Blind, Clinical Trial

The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

NCT04359316 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin

54 Efficacy and Safety of Favipiravir Compared to the Base Therapeutic Regiment in Moderate to Severe COVID-19: A Randomized, Controlled, Double-Blind, Clinical Trial

The present study is a randomized, double-blind, controlled, clinical trial, with the approval of the ethics committee will be conducted on patients who have a positive test confirming COVID-19 in Shahid Modarres Medical Education Center and Hospital in Tehran. Patients will be randomly assigned to the two arms of the study and after completing the course of treatment and collecting and analyzing the necessary information from each patient, the results of the study will be published both on this site and in the form of an article in a reputable international journal.

NCT04359615 COVID-19 Drug: Favipiravir Drug: Hydroxychloroquine

55 Efficacy of Hydroxychloroquine, Telmisartan and Azithromycin on the Survival of Hospitalized Elderly Patients With COVID-19: a Randomized, Multicenter, Adaptative Study

In November 2019, Wuhan city in China, became the center of an outbreak of pneumonia due to a novel coronavirus SARS-CoV-2, which disease was named coronavirus disease 2019 (COVID19) in February, 2020. The COVID19 is much more dangerous for people over 60 with a death rate of 3.6% after 60, 8.0% after 70 and 14.8% after 80 -and according to our Italian colleagues over 20% after 90- against 2.3% in the general population. The elderly patients who died most often had multiple comorbidities and in particular: cardiovascular disease (10.5% mortality), diabetes (7.3%), chronic respiratory disease (6.3%) and hypertension (6%). These elderly patients with COVID19 are therefore very fragile and require treatment that fights the virus but is also adapted to their state of health and age. Most of current therapeutic trials worldwide exclude people aged over 75 years, which is precisely the age group affected by COVID19. We therefore propose to carry out a therapeutic trial specific to the elderly with drugs at doses that are bearable for these patients. Using the WHO, clinicaltrial, pubmed and the Chinese CCDC/CHCTR websites to find the better drugs adapted to elderly people, we decided after concertation between infectiologists and geriatricians to do a four arms clinical trial during two weeks twice a day: Hydroxychloroquine 200mg, Telmisartan 40mg, Azithromycin 250mg and standard care. We therefore hypothesize that one or more of these treatments may have a beneficial effect in controlling COVID19, without major and repeated side effects in elderly patients.

NCT04359953 COVID-19 Infection Drug: Hydroxychloroquine Drug: Azithromycin Drug: Telmisartan

56 An Open Label Cluster Randomized Controlled Trial of Chloroquine, Hydroxychloroquine or Only Supportive Care in Patients AdmItted With Moderate to Severe COVID-19

Rationale: Currently there are no approved treatments for COVID-19. In the Dutch treatment protocol guideline (SWAB) designated treatment is supportive care with the option to add chloroquine base (CQ) or hydroxychloroquine (HCQ). CQ and HCQ are implemented because of their in vitro activity, results from small animal studies, and anecdotal patient's data. There are no published randomized studies with these medications in patients with disease caused by any coronavirus. Objective: To evaluate if treatment with only supportive care or addition of one of two anti-COVID_19 agents (chloroquine or hydroxychloroquine) results in less disease progression in patients with moderate to severe COVID-19 who require hospital admission. Study design: Multicentre, cluster randomized cross-over, open label trial. Hospitals will be randomly allocated to one of 3 treatment arms in sequential periods of one week: chloroquine base versus hydroxychloroquine versus supportive care without any drug presumed active against SARS-COV-2. Patients will be treated based on the date of inclusion. Study population: Adults aged of 18 years and older with moderate to severe, with a NEWS-2 score ≤ 5, laboratory confirmed COVID-19, who require hospital admission in a ward outside the Medium Care or Intensive Care. Intervention (if applicable): Depending on the treatment arm, the study subject will receive only supportive care or an addition with one of the two agents active against SARS-CoV-2 (chloroquine or hydroxychloroquine). Main study parameters/endpoints: Disease progression defined as a NEWS-2 score ≥ 7 within 14 days, or admission to Medium Care or Intensive Care Unit, or death.

NCT04362332 COVID-19 Drug: Chloroquine Sulfate Drug: Hydroxychloroquine Other: Standard supportive care

57 VA Remote and Equitable Access to COVID-19 Healthcare Delivery (VA-REACH TRIAL)

We propose a 3-arm RCT to determine the efficacy of hydroxychloroquine or azithromycin in treating mild to moderate COVID-19 among Veterans in the outpatient setting.

NCT04363203 SARS-CoV-2 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin Drug: Placebo oral tablet

58 Hydroxychloroquine as Primary Prophylaxis for COVID-19 in Healthcare Workers (HCQPreP)

This a double-blind, randomized, placebo-controlled clinical trial to determine if primary prophylaxis with hydroxychloroquine in healthcare workers reduces symptomatic COVID-19 infection. Healthcare workers will be randomized at a 1:1 allocation between intervention and placebo arms and followed for 12 weeks. This study will enroll up to 1,700 participates in Lafayette, Louisiana. The primary outcome will number of symptomatic COVID-19 infections. Secondary endpoints included number of days healthcare workers are absent from work and rate of severe infection.

NCT04363450 COVID-19 Corona Virus Infection Wuhan Coronavirus Prophylaxis Healthcare Worker Sars-CoV2 Hydroxychloroquine Drug: Hydroxychloroquine Drug: Placebo

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases

59 PROTECT: A Randomized Study With Hydroxychloroquine Versus Observational Support for Prevention or Early Phase Treatment of Coronavirus Disease (COVID-19)

This is a Italian, superiority, open label cluster-randomised, interventional clinical trial aimed at assessing whether the treatment with Hydroxychloroquine can reduce the percentage of symptomatic subjects compared to observation only in household members/contacts of COVID-19 patients (Group 1) and if the treatment with Hydroxychloroquine could be introduced in early phase COVID-19 population (Group 2). The participants will be randomised to receive either: Arm A) hydroxychloroquine vs Arm B) Observation (2:1 randomisation).

NCT04363827 COVID19 Hydroxychloroquine Prophylaxis Treatment SARS-CoV-2 Drug: Hydroxychloroquine

MeSH:Coronavirus Infections

60 A Randomized-Control Pilot Study to Assess Hydroxychloroquine in Patients Infected With SARS-CoV-2 (COVID-19)

This is a prospective, randomized, participant-blinded, placebo-controlled, pilot study to assess the preliminary efficacy and safety of hydroxychloroquine for the treatment of patients with lower respiratory tract SARS-CoV-2 infection.

NCT04363866 COVID-19 SARS-CoV-2 Drug: Hydroxychloroquine Drug: Placebo

61 A Randomized Trial of Efficacy and Safety of an Early OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome: a Strategy to Prevent Hospitalization

COVID-19 is a respiratory disease due to a novel coronavirus (SARS-CoV-2) that causes substantial morbidity and mortality. To date, no treatment has been proved to be effective in COVID-19. Elderly patients and patients with comorbidities have the worse prognosis with a higher risk of hospitalization, ICU admission and death. The efficacy of an early outpatient treatment could be suggested but need to be confirmed. This confirmation is mandatory to improve prognosis of COVID-19 but also to avoid unsuspected deleterious effect of drugs already used in clinical practice but not based on evidence.

NCT04365582 COVID Drug: Azithromycin Drug: Hydroxychloroquine Drug: Lopinavir 200Mg/Ritonavir 50Mg Tab

62 Efficacy and Safety of Hydroxychloroquine in Primary Prophylaxis of SARS-CoV-2 Infection in Healthcare Workers at Risk of Exposure: Randomised Control Trial

Healthcare personnel are at an increased risk of exposure to SARS-CoV-2 infection while handling such patients. Currently, there is no treatment available for SARS-CoV-2 and stringent preventive measures are advised to avoid or minimize risk of exposure to healthcare workers. There are in vitro studies available which show inhibition of corona virus by hydroxychloroquine, a widely-used agent against malaria and certain autoimmune conditions and of low-cost and limited toxicity. However, evidence regarding its effects in patients is limited. We plan to conduct a randomized controlled trial to evaluate the safety and potential prophylactic efficacy of hydroxychloroquine in preventing secondary SARS-CoV-2 infection among healthcare workers at high-risk of exposure while managing such patients.

NCT04370015 SARS-CoV-2 Healthcare Workers Drug: Hydroxychloroquine Drug: Placebo oral tablet

MeSH:Infection

63 A Randomized Study Evaluating the Safety and Efficacy of Hydroxychloroquine and Zinc in Combination With Either Azithromycin or Doxycycline for the Treatment of COVID-19 in the Outpatient Setting

This is a randomized, open-label trial to assess the safety and efficacy of hydroxychloroquine, and zinc in combination with either azithromycin or doxycycline in a higher risk COVID-19 positive outpatient population.

NCT04370782 COVID-19 Drug: Hydroxychloroquine Drug: Azithromycin Drug: Zinc Sulfate Drug: Doxycycline

64 Efficacy of HYdroxychloroquine and DILtiazem-nIClosamide Combination for the Treatment of Non-severe Forms of SARS-CoV2 Infection in Patients With Co-morbidities: Multicenter, Randomized, Open-labeled Controlled Trial

No optimal antiviral intervention has been yet validated to treat COVID-19 disease. Comorbidities, such as older age, obesity, diabetes, history of cardiovascular diseases are associated with poor prognosis. This study aims to evaluate the efficacy of two experimental antiviral treatments, compared to standard of care (SOC), to prevent clinical worsening, hospitalization or death at day 14 in adults with documented SARS-CoV-2 infection, asymptomatic or with symptoms lasting less than 8 days, and associated comorbidities without any severity criteria of the disease at inclusion. Participants will be randomized to receive SOC alone or SOC + hydroxychloroquine 200 mg three times a day during 10 days or SOC + association of niclosamide 2 g at J1 then 500 mg two times a day with diltiazem 60 mg three times a day during 10 days. Efficacy and tolerance of each treatments will be compared across the three treatment groups during the 28 days of follow-up.

NCT04372082 Sars-CoV2 Other: Standard of care (SOC) Drug: Hydroxychloroquine Drug: Association of diltiazem and niclosamide

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