There are 318 clinical trials

Clinical Trials

1 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

2 An Investigation of the Inflammatory Response in Severe Acute Respiratory Syndrome (SARS)

Severe Acute Respiratory Syndrome (SARS) is a newly recognized illness that can be fatal. The purpose of this study is to better understand SARS by collecting samples of blood and other body fluids of people who have been exposed to SARS or who are suspected to have the illness. Up to 300 volunteers aged 18 years or older will be enrolled in this study. Participants will donate blood samples and, if appropriate, samples of fluid from the lungs, nose, or throat. Researchers will test these samples for proteins that control or mediate inflammatory or immune responses. The patterns of these proteins will reveal how SARS affects the body and the efforts the body makes to fight off the infection.

NCT00066209 SARS Virus

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

3 Clinical Evaluation and Management of Persons With Severe Acute Respiratory Syndrome (SARS)

This study will evaluate and treat people with SARS, a new type of pneumonia (lung infection) originating in China. SARS is caused by a new virus that is easily transmitted from person to person. This study will look at the course of the disease; determine how the virus affects the body and how the body fights the infection; and evaluate diagnostic tests to quickly identify the disease. People 18 years of age and older with probable or suspected SARS may be eligible for this study. Close contacts of patients with SARS, patients who recovered from SARS, and NIH health care workers involved in the care of patients will also be enrolled. Patients with SARS who require hospitalization will be admitted to the NIH Clinical Center. Because SARS spreads easily, hospitalized patients will be in a room by themselves and will not be allowed any visitors. They will not leave their room except for tests, such as x-rays. All participants will have a full medical examination, including a medical history, physical examination, and blood tests. In addition, the participants undergo various tests and procedures as follows: - Probable and suspected SARS patients may be hospitalized or may be seen as outpatients. They are provided the treatment judged best for their disease, usually according to expressed or published recommendations. The best treatment for SARS is not yet known, and there have been no studies evaluating therapies. Outpatients are seen three times a week for 2 weeks, once a week for 4 more weeks, and then at 6 months. Patients have mouth and throat swabs taken three times a week for the first 2 weeks, then once a week for 4 more weeks. Blood is drawn three times a week for the first 2 weeks, then once at weeks 3, 4, and 6. If virus is still detectable after 6 weeks, nose washings and throat swabs are repeated until no virus is detected for 3 weeks in a row. In addition, patients provide urine and stool samples, have a chest x-ray and electrocardiogram, and undergo bronchoscopy and bronchial lavage. For the bronchoscopy, a bronchoscope (pencil-thin flexible tube) is passed into the large airways of the lung, allowing the physician to examine the airways. Cells and secretions from the airways are rinsed from the lung with salt water. A brush the size of a pencil tip is passed through the bronchoscope to scrape cells lining the airways and pieces of tissue are collected for analysis. - Close contacts of patients are evaluated twice a week for 2 weeks, then once a week for 2 more weeks. Blood is drawn at the first visit and then at 1, 2, and 4 weeks. Mouth and throat swabs, nose washings, and sputum collections are done twice a week for 2 weeks, then once a week for 2 more weeks. Urine and stool samples are collected once a week for 4 weeks. If virus from the nose or throat is still detectable after 4 weeks, weekly nose washings and throat swabs continue until no virus is detected for 3 weeks in a row. Blood may also be drawn during the weekly visits. - Recovered SARS patients provide blood, urine, and stool samples and have a mouth and throat swab and nose aspiration to see if the SARS virus is present. For the nasal aspiration, salt water is put in the nose and then suctioned out. Usually, these tests are done only once. If virus is detected, however, the nose washing, throat swabs and blood tests are repeated once a week until no virus is detected for 3 weeks in a row. - Health care workers document their contact with patients, use of isolation procedures and equipment, and any unexpected events that occur during contact. They are evaluated for symptoms of infection and provide a blood sample once a month

NCT00073086 Severe Acute Respiratory Syndrome

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Syndrome

4 Contamination During Removal of Two Different Personal Protective Systems When Working Under Conditions Requiring Enhanced Respiratory and Contact Precautions

Highly communicable and virulent diseases, the ongoing threat of emerging infectious diseases, and the prospect of bio-terrorism have become part of the new reality for health care workers. SARS transmission has occurred despite the use of droplet, contact, and airborne precautions. Potential explanations for some of the episodes of “through-precautions” transmission include the possibility of contamination during removal of protective clothing. The recommended protective systems (PPS) for aerosol generating procedures set out by the US Center for Disease Control and Prevention (CDC) and the Ontario Ministry of Health and Long Term Care (MOHLTC) differ. The failure of a PPS may be associated with significant consequences in terms of the morbidity and mortality of front-line health care workers. The purpose of this study is to determine if a difference exists between the rate of self-contamination due to deficiencies in contact precautions for individuals wearing either the CDC or MOHLTC recommended PPS. Study participants will don one of the two recommended PPS, be “contaminated” with an indicator that becomes visible under ultraviolet light, and then assessed for contamination of clothing layers and skin after removal of the PPS. They will then repeat the procedure using the other PPS.

NCT00150475 Severe Acute Respiratory Syndrome Procedure: Powered Air purifying respirator

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

5 The Interaction Between Severe Acute Respiratory Distress Syndrome Viral Proteins and Monocytes

Severe acute respiratory syndrome (SARS) is a new threat to public health since November, 2002. The SARS is highly contagious and is believed to be transmitted by person-to-person through droplet and direct contact. The patients present with fever, chills, cough, myalgia, dyspnea, and diarrhea. The symptoms aggravate in the second week and nearly 40% of the patients develop respiratory failure that requires assisted ventilation. The mortality rate is reported as 6.5%-7%. After several months, the world scientists found the etiology to be a new coronavirus not belonging to the previous coronavirus group I, II and III. The new virus is called SARS associated coronavirus (SARS-CoV). Although the high morbidity and mortality of SARS occurred in adults, there was rare mortality reported in the children. The report from Hong Kong pointed out that the symptoms of SARS in younger children were milder and the clinical course was not as aggressive as in adults. Therefore, the aim of the project is to design the experiment to see the differences of immunological responses to SARS-CoV protein in healthy younger children, teenagers, and adults. The investigators hope that the result could explain the reason for milder disease in younger children and the immunological pathogenesis of SARS.

NCT00172263 Severe Acute Respiratory Syndrome Procedure: blood sampling

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Syndrome

6 A Randomized, Dose-ranging Study of Alferon® LDO {Low Dose Oral Interferon Alfa-n3 (Human Leukocyte Derived)} in Normal Volunteers and/or Asymptomatic Subjects With Exposure to a Person Known to Have SARS or Possible SARS

The purpose of this trial is to conduct a randomized dose-ranging study to evaluate the safety and activity of orally administered low dose interferon alfa-n3 as an antiviral and immunomodulator in asymptomatic subjects with recent exposure to a person with severe acute respiratory syndrome (SARS) or possible SARS. The primary objective of this pilot study is to determine an Alferon LDO dose level that increases or upregulates genes known to be mediators of interferon response. Secondary endpoints include the development of SARS symptomatology, rate of hospitalization, and mortality rate. In the event that no subjects with recent exposure to a person with SARS or possible SARS are available, this study will be conducted with 10 normal volunteers.

NCT00215826 Severe Acute Respiratory Syndrome Drug: Alferon LDO

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

7 Collection of Convalescent SARS Plasma by Apheresis

The purpose of this study is to collect plasma by apheresis from patients who have recovered from Severe Acute Respiratory Syndrome (SARS). This plasma will be processed into a SARS-antibody enriched intravenous immune globulin (IVIG) product. This product will then be available for use in a clinical trial if a SARS epidemic recurs. Potentially eligible participants are people between 18 and 56 years of age who have recovered from SARS. Potential participants will undergo three sequential screenings to determine their eligibility for this study. Eligible participants will then be scheduled for plasmapheresis. After apheresis, additional testing will be performed on a sample of the source plasma. Once the sample has been tested and cleared, the source plasma will be shipped to the United States to the storage facility and finally to the site of manufacturing of the IVIG product. Participants may donate plasma again after 14 days. The study will not have a direct benefit for participants. However, participation may help develop a treatment that could be useful to other people who become infected with SARS.

NCT00342524 Severe Acute Respiratory Syndrome SARS

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

8 Immune Responses, Transmission and Nucleotide Polymorphisms in Families With SARS Virus Infections

The purpose of this study is to understand how severe acute respiratory syndrome (SARS) spreads within families, if significant disease resulted, and how the body responds to SARS. The study will also explore the affects of SARS on genetics and the immune system (the body system that fights disease). Up to 1000 people residing in Beijing, China may be involved in this study. Adult survivors of SARS (numbering 200) and their family members including children age 4 and up will be asked to participate in the study. The study will recruit an additional 200 persons, who will be matched with SARs survivors of similar age, gender, health status, and housing/work location, and recruited as comparators. Blood will be taken from all volunteers and tested for the presence of SARS antibodies (proteins made by the body's immune system in response to something that can cause infection). Health and clinic/hospital visit records may be reviewed.

NCT00523276 Coronavirus (SARS-CoV)

MeSH:Coronavirus Infections

9 Phase I, Double-Blinded, Placebo-Controlled Dosage Escalation Study of the Safety and Immunogenicity of Adjuvanted and Non-Adjuvanted Inactivated SARS Coronavirus (SARS-CoV) Vaccine Administered by the Intramuscular Route

Severe acute respiratory syndrome (SARS) is a viral illness that affects the respiratory (breathing) system. The purpose of this study is to evaluate the safety and protective (immune) responses to different doses of a SARS vaccine given with or without an adjuvant. An adjuvant is a substance that may be added to a vaccine to improve the immune response so that less of the vaccine may need to be given. Study participants will include 72 volunteers, ages 18-40, living in the Houston, Texas area. The study will take place at Baylor College of Medicine. Participants will receive 2 injections of vaccine or placebo (substance made to look like the study vaccine but contains no medication) given 1 month apart. Participants will fill out a memory aid (diary) to document daily temperature and illness signs and symptoms for 7-9 days after each injection. During the 9 study visits, several blood samples will be collected. Participants will be in the study for up to 211 days, including screening.

NCT00533741 Coronavirus (SARS-CoV) Drug: Aluminum hydroxide Drug: Placebo Biological: SARS-CoV

MeSH:Coronavirus Infections

10 A Multi-centre, Double-blinded, Randomized, Placebo-controlled Trial on the Efficacy and Safety of Lopinavir / Ritonavir Plus Ribavirin in the Treatment of Severe Acute Respiratory Syndrome

The study aims to examine whether the combination of Lopinavir/Ritonavir plus Ribavirin for treatment of severe acute respiratory syndrome (SARS) is superior to placebo.

NCT00578825 Severe Acute Respiratory Syndrome Drug: Lopinavir / Ritonavir plus Ribavirin

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections Syndrome

11 An International Observational Study to Characterize Adults Who Are Hospitalized With Influenza or Other Targeted Respiratory Viruses

Following the sudden and unexpected emergence of influenza A(H1N1)pdm09 (2009 H1N1) virus, this observational study was initiated to estimate rates of morbidity and mortality and to examine predictors of severity among participants with 2009 H1N1 infection. In 2011, as surveillance indicated that 2009 H1N1 virus was co-circulating with other seasonal influenza A and B viruses worldwide, the protocol was expanded to include other influenza A subtypes and influenza B viruses. The current version of the protocol (released in August 2013) further broadens the scope of this observational study. With the recognition that novel respiratory viruses other than novel influenza A viruses, e.g., Middle East Respiratory Syndrome Coronavirus (MERS-CoV), could become prevalent and of major public health importance, the objectives of this protocol have been expanded.

NCT01056185 Influenza Novel Respiratory Virus-1 Middle Eastern Respiratory Syndrome Coronavirus (MERS-CoV) Novel Respiratory Virus-2 Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)

MeSH:Influenza, Human Coronavirus Infections Severe Acute Respiratory Syndrome Syndrome Virus Diseases

12 Testing of Respiratory Specimens for the Validation of the QIAGEN ResPlex II Advanced Panel Test and the Artus Influenza A/B RT-PCR Test

The study will be conducted using nasopharyngeal swab specimens collected prospectively from individuals suspected of having the signs and symptoms of an acute respiratory tract infection caused by a respiratory virus. A series of standard viral culture tests validated for routine use in the clinical laboratory, and/or a series of PCR-based Laboratory Developed Tests (PCR-LDT) validated by a central reference laboratory will be used to verify the performance of the investigational artus Influenza A/B RT-PCR test and the QIAGEN ResPlex II Advanced Panel test. From each specimen five (5) aliquots will be prepared: (a) one aliquot will be tested in real-time using the assigned viral culture reference methods; (b) one aliquot will be used to extract nucleic acid in real-time for investigational testing; (c) one aliquot of the specimen will be stored at --70C for subsequent shipment to the reference laboratory for PCR-LDT testing, (d) one aliquot will be archived at -70C for subsequent follow-up by the reference laboratory (e.g., bi-directional sequencing of positive specimens), and (e) any remaining specimen will be stored for the Fresh vs. Frozen Study. The extracted nucleic acid generated from the second aliquot (i.e., "b" above) will be split and subjected to testing by both the artus Influenza A/B RT-PCR test and the ResPlex II Advanced Panel test.

NCT01302418 QIAGEN ResPlex II Advanced Panel Influenza A Respiratory Sy Respiratory Syncytial Virus Infections Infection Due to Human Parainfluenza Virus 1 Parainfluenza Type 2 Parainfluenza Type 3 Parainfluenza Type 4 Human Metapneumovirus A/B Rhinovirus Coxsackie Virus/Echovirus Adenovirus Types B/C/E Coronavirus Subtypes 229E Coronavirus Subtype NL63 Coronavirus Subtype OC43 Coronavirus Subtype HKU1 Human Bocavirus Artus Influenza A/B RT-PCR Test Influenza B Device: artus Influenza A/B RT-PCR Test

MeSH:Infection Communicable Diseases Influenza, Human Coronavirus Infections Adenoviridae Infections Respiratory Syncytial Virus Infections Paramyxoviridae Infections Coxsackievirus Infections Virus Diseases

13 Seroprevalence of IgG Antibodies to Middle East Respiratory Syndrome Coronavirus in Asymptomatic Healthcare Workers After Treatment of Confirmed MERS Patient

The investigators aim to do serosurvey of healthcare-personnel who had participated in treatment of confirmed patients of Middle-East respiratory syndrome. The investigators collected the base-line (pre-exposure) serum of healthcare-personnel in a few centers, and will collect the post-exposure serum from about 25-30 centers in which confirmed MERS patients had been treated. The investigators will deduct the seroprevalence of MERS-CoV IgG among the healthy healthcare-personnel, and calculate the sero-conversion rate if possible. The investigators will subdivided the seroprevalence according to the degree of exposure and preparedness of personal protective equipment.

NCT02497885 Coronavirus Infections

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

14 A Phase 1, Randomized Double-Blind, Placebo-Controlled, Single Ascending Dose Safety, Tolerability, and Pharmacokinetics Study of SAB-301 in Healthy Adults

Background: Middle East Respiratory Syndrome (MERS) is a newly discovered contagious and sometimes fatal respiratory virus. People often get MERS through close contact with an infected person. Scientists are worried that MERS may spread and cause more infections. There are no vaccines or treatments for MERS right now. Researchers think a new therapy called SAB-301 may be able to help. Antibodies are proteins the body makes to attack viruses. SAB-301 is made of antibodies made in cows to fight MERS. The antibodies are collected from plasma, the liquid part of cow blood. Objective: To evaluate the safety and tolerability of SAB-301 in healthy adults. Eligibility: Healthy people ages 18 60 who: Do not have chronic medical problems Do not take any medications (exceptions are acetaminophen, ibuprofen, vitamins, seasonal allergy meds and oral contraception) Do not have allergies to beef products Agree to use two forms of contraception while on study (both men and women) Design: Participants will be screened with: Medical history Physical examination Blood and urine tests Participants will have a return visit. They will have a physical exam and blood tests. They will be randomly assigned to receive either SAB-301 or a placebo which is given by infusion through an arm vein over 1 3 hours. They will be monitored at the clinic for 6 hours after the infusion. They will have additional blood draws. Participants will have 2-hour visits 1, 3, 7, 21, 42, and 90 days after the infusion. At each visit they will be evaluated and have blood and urine tests.

NCT02788188 Middle East Respiratory Syndrome Coronavirus Biological: SAB-301 Other: Normal (9%) Saline

MeSH:Coronavirus Infections

15 MERS-CoV Infection tReated With A Combination of Lopinavir /Ritonavir and Interferon Beta-1b: a Multicenter, Placebo-controlled, Double-blind Randomized Trial

This is a placebo-controlled clinical trial to assess the feasibility, efficacy and safety of a combination of lopinavir/ritonavir and Interferon beta-1b in hospitalized patients with MERS.

NCT02845843 Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Drug: Combination of Lopinavir /Ritonavir and Interferon beta-1b Drug: Placebo

MeSH:Coronavirus Infections

16 Implementation of Lung Protective Ventilation in Patients With Acute Respiratory Failure

This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a proven standardized lung protective ventilation protocol in the new electronic medical record system iCentra across all Intermountain Healthcare hospitals. Approximately 14,000 records will be accessed for this study from a database of mechanically ventilated patients established for quality improvement purposes. The investigators hypothesize that implementation of a standardized computerized lung protective ventilation protocol across all Intermountain Healthcare hospitals will be feasible, will decrease initial tidal volumes to the target 6 ml/kg PBW, and will improve outcomes. The objectives of this study are to: - Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in patients with acute respiratory failure requiring mechanical ventilation - Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in the sub-group of patients with the acute respiratory distress syndrome (ARDS) - Measure compliance with the implementation of a computerized lung protective ventilation protocol at 12 Intermountain Healthcare hospitals

NCT03225807 Acute Respiratory Distress Syndrome ARDS Respiratory Distress Syndrome, Acute Respiratory Insufficiency Respiratory Distress Syndrome Shock Lung Severe Acute Respiratory Syndrome

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

HPO:Pulmonary insufficiency

17 A Phase I Trial to Evaluate the Safety, Tolerability, Pharmacokinetics and Immunogenicity of Co-administered MERS-CoV Antibodies REGN3048 and REGN3051 vs. Placebo in Healthy Adults

This is a Phase 1, first-in-human (FIH), single site, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and immunogenicity of single ascending doses of a co-administered (1:1, w/w) combination of REGN3048 and REGN3051 mAb's, administered IV in healthy adult volunteers. Study duration of approximately 16 months. Approximately 48 evaluable subjects will be enrolled in the study, eight (8) subjects in each one of 6 sequential ascending IV dose cohorts. In each cohort, subjects will be randomized to receive mAb's REGN3048 and REGN3051 (6 subjects) or placebo (2 subjects). Primary Objective: To assess the safety and tolerability of REGN3048 and REGN3051 following co-administration of single, ascending IV doses of 1.5, 5, 15, 25, 50, and 75 mg/kg of each of the two mAb's.

NCT03301090 Corona Virus Infection Other: Placebo Biological: REGN3048 Biological: REGN3051

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases

18 An Open Label Safety Study of Inhaled Gaseous Nitric Oxide (gNO) for Adults & Adolescents With Non-Tuberculous Mycobacteria, Burkholderia Spp, Aspergillus Spp and Corona-like Viral (Sub-Study) Infections

Non tuberculous mycobacteria (NTM), Burkholdria spp, Aspergillus in the lung are almost impossible to eradicate with conventional antibiotics. In addition COVID-19 has know current treatment. These patients have few options to treat their lung infection. Nitric oxide has broad bactericidal and virucidal properties. It has been shown that nitric oxide was safe to be inhaled for similar cystic fibrosis patients and reduced drug resistant bacteria in the lungs. Further, research indicates that clinical isolates of NTM, Burkholderia spp, Aspergillus spp and Corona-like viruses can be eradicated by 160ppm NO exposure in the laboratory petri dish. This is not the first time inhaled NO treatment has been used in patients with difficult lung infections. This study will provide more data to see if NO therapy can reduce the bacterial load in the lungs, help the patients breath better; and in the case of COVID-19 act as a anti-viral agent resulting in the reduction of incidence of oxygen therapy, mechanical assistance of BIPAP, CPAP, intubation and mechanical ventilation during the study period.

NCT03331445 Respiratory Tract Infections Corona Virus Infection Drug: Nitric Oxide 0.5 % / Nitrogen 99.5 % Gas for Inhalation

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

HPO:Respiratory tract infection

19 A Phase I Study to Determine the Safety and Immunogenicity of the Candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Vaccine ChAdOx1 MERS in UK Healthy Adult Volunteers

This is a clinical trial in which healthy volunteers will be administered an experimental MERS vaccine. The vaccine ChAdOx1 MERS will be administered alone both as a single administration and with a homologous prime-booster.

NCT03399578 MERS (Middle East Respiratory Syndrome) Biological: ChAdOx1 MERS

MeSH:Coronavirus Infections Syndrome

20 The 15-year Impact of Severe Acute Respiratory Syndrome on Organ Functions, Exercise Capacity, and Quality of Life in Survivors.

SARS-CoV has caused severe epidemic respiratory disease in human populations. By July 2003, a total of 8,096 probable cases of SARS had been reported including 774 deaths in 27 countries, around one-third of which were health care workers (HCWs). Previous studies have been reported about long-term impacts of SARS infection, including lung function deficiency, steroid-induced osteonecrosis, reduced exercise capacity, and impairment in health-related quality of life (HRQoL). HCWs, especially nurses, have been reported to experience greater psychological distress, particularly increased levels of posttraumatic stress symptomatology (PTSS). But the very complex impacts of this fatal infection on HCWs have not been fully elucidated. It is thus important to follow these occupational patients to detect and manage multi-organ sequelae and functional impairment.

NCT03443102 SARS Virus Long-Term Survivors

MeSH:Severe Acute Respiratory Syndrome Coronavirus Infections

21 Streptokinase Versus Unfractionated Heparin Nebulization in Patients With Severe Acute Respiratory Distress Syndrome (ARDS): A Partially Randomized Controlled Trial

Background: Intra-alveolar clotting and alveolar collapse in ARDS is due to alveolar capillaries epithelial and leakage. Subsequently, collapse induces hypoxemia that is resistant to recruitment (RM). Heparin and Streptokinase may prevent or dissolve intra-alveolar fibrin clot respectively helping alveolar re-expansion. We examined and compared the effect of nebulizing Heparin versus Streptokinase on reversing this pathology. Methods: Sixty severe ARDS (PaO2/FiO2<100) patients and failure of RM, prone position (PP) and neuromuscular block (NMB) were partially randomised into Group (I): (n=20) received nebulized Heparin 10000 IU/4h. Group (II): (n=20) received nebulized Streptokinase 250,000 IU/4h. Group (III): (n=20) received conservative management. Randomization to either Heparin or Streptokinase groups was applied to patients whom guardian accepted participation, while those who declined participation were followed-up as a control. The primary outcome was the change in PaO2/FiO2; the secondary outcomes included the change in compliance, plateau pressure, ventilation-off days, coagulation and ICU mortality.

NCT03465085 Acute Respiratory Distress Syndrome Severe Acute Respiratory Syndrome Drug: Unfractionated heparin Drug: Streptokinase

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

22 An Open, Single Center Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-MERS-S

The Middle East Respiratory Syndrome Coronavirus (MERS-CoV) is a potentially fatal disease with a reported lethality of up to 40% that is under tight epidemiologic control by the World Health Organization (WHO) and currently without registered prevention or treatment option. In this phase I first-in-human clinical trial, healthy volunteers in two different dose cohorts will be vaccinated twice with the candidate vaccine MVA-MERS-S. A subgroup will additionally receive a late booster vaccination. The aim of the study is to assess the safety and tolerability of the candidate vaccine and to characterize its immunogenicity.

NCT03615911 MERS (Middle East Respiratory Syndrome) Biological: vaccine candidate MVA-MERS-S

MeSH:Coronavirus Infections

23 An Open Label, Dose-Escalation, Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetics of TAK-981 in Adult Patients With Advanced or Metastatic Solid Tumors or Relapsed/Refractory Hematologic Malignancies and in a Subset With Coronavirus Disease 2019

The primary objective of this study is to evaluate the safety and tolerability of TAK-981 as a single agent in participants with advanced or metastatic solid tumors and lymphomas in dose escalation and cancer treatment expansions, and to assess change in acute respiratory syndrome coronavirus 2 (SARS-CoV-2) viral load within 8 days of TAK-981 administration in COVID expansion.

NCT03648372 Neoplasms Lymphoma Hematologic Neoplasms Coronavirus Disease Drug: TAK-981 Drug: Standard of care

MeSH:Coronavirus Infections Hematologic Neoplasms Neoplasms

HPO:Hematological neoplasm Leukemia Neoplasm

24 Lessening Organ Dysfunction With VITamin C (LOVIT)

LOVIT is a multicentre concealed-allocation parallel-group blinded randomized controlled trial to ascertain the effect of high-dose intravenous vitamin C compared to placebo on mortality or persistent organ dysfunction at 28 days in septic intensive care unit patients. Patients with COVID-19 are considered eligible for this study.

NCT03680274 Sepsis Vitamin C Intensive Care Unit COVID-19 Pandemic Coronavirus Drug: Vitamin C Other: Control

MeSH:Coronavirus Infections

25 A Two-center, Randomized, Double-blind, Placebo-controlled, Phase Ib Study to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-MERS-S_DF-1 in Healthy Study Subjects

The study will be a two center, randomized, double blind, placebo controlled study of the MVA MERS S_DF-1 candidate delivered by i.m. injection. To evaluate the MERS-S-specific antibody responses and safety profile induced by the two dosage levels of MVA-MERS-S_DF-1 the data will be compared to a placebo control group.

NCT04119440 MERS (Middle East Respiratory Syndrome) Biological: MVA-MERS-S_DF1 - Low Dose Biological: MVA-MERS-S_DF1 - High Dose Other: Placebo

MeSH:Coronavirus Infections

26 Double-blind, Placebo-controlled Study With an Open Dose Selection Period for Assessing the Safety and Immunogenicity of the Drug "BVRS-GamVac-Combi", a Combined Vector Vaccine for the Prevention of the Middle East Respiratory Syndrome, Lyophilisate for the Preparation of a Solution for Intramuscular Administration, With the Participation of Healthy Volunteers

The Middle East respiratory syndrome coronavirus (MERS-CoV) was identified in 2012 during the first Middle East respiratory syndrome (MERS) outbreak. MERS-CoV causes an acute lower-respiratory infection in humans, with a fatality rate of ~34.5%. The aim of the study is to assess the safety and immunogenicity of heterologous adenoviral-based vaccine against MERS - BVRS-GamVac-Combi.

NCT04128059 MERS (Middle East Respiratory Syndrome) MERS Drug: BVRS-GamVac-Combi Other: placebo

MeSH:Coronavirus Infections Syndrome

27 Double-blind, Placebo-controlled Study With an Open Dose Selection Period for Assessing the Safety and Immunogenicity of the Drug "BVRS-GamVac", a Vector Vaccine for the Prevention of the Middle East Respiratory Syndrome, Lyophilisate for the Preparation of a Solution for Intramuscular Administration, With the Participation of Healthy Volunteers

The Middle East respiratory syndrome coronavirus (MERS-CoV) was identified in 2012 during the first Middle East respiratory syndrome (MERS) outbreak. MERS-CoV causes an acute lower-respiratory infection in humans, with a fatality rate of ~34.5%. The aim of the study is to assess the safety and immunogenicity of adenoviral-based vaccine against MERS - BVRS-GamVac.

NCT04130594 MERS (Middle East Respiratory Syndrome) MERS Biological: BVRS-GamVac Other: placebo

MeSH:Coronavirus Infections Syndrome

28 A Phase Ib Study to Determine the Safety and Immunogenicity of the Candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) Vaccine ChAdOx1 MERS in Healthy Adult Middle Eastern Volunteers

A phase Ib study to determine the safety and immunogenicity of the candidate Middle East Respiratory Syndrome Coronavirus (MERS-CoV) vaccine ChAdOx1 MERS in healthy adult Middle Eastern volunteers

NCT04170829 Middle East Respiratory Syndrome Coronavirus Biological: ChAdOx1 MERS

MeSH:Coronavirus Infections Syndrome

29 Development of a Simple, Fast and Portable Recombinase Aided Amplification (RAA) Assay for 2019-nCoV

In late December 2019, several local health facilities reported clusters of patients with pneumonia of unknown cause that were epidemiologically linked to a seafood and wet animal wholesale market in Wuhan, Hubei Province, China. It is now confirmed that the etiology of this outbreak is a novel coronavirus, namely, 2019-nCoV. Of critical importance is rapid and simple diagnostic method to be used in clinical settings to timely inform and refine strategies that can prevent, control, and stop the spread of 2019-nCoV. Recombinase aided amplification (RAA) assay is a novel isothermal nucleic acid amplification technique in recent years, which has a variety of the advantages including high specificity and sensitivity, rapid detection (30 min), low cost, low equipment requirements and simple operation. The has successfully detected a variety of pathogens using this technique. To develop a RAA assay for 2019-nCoV with the advantages of high speed, simple operation and low cost, and overcomes the shortcomings of the existing molecular detection methods. The investigators established a real time reverse-transcription RAA (RT-RAA) assay for detection of 2019-nCoV. This assay was performed at 42°C within 30min using a portable real-time fluorescence detector, Recombinant plasmids containing conserved ORF1ab genes was used to analyze the specificity and sensitivity. Clinical specimens from patients who were suspected of being infected with 2019-nCoV were used to evaluate the performance of the assay. In parallel, The investigators also used the commercial RT-qPCR assay kit for 2019-nCoV as a reference.

NCT04245631 New Coronavirus Diagnostic Test: Recombinase aided amplification (RAA) assay

MeSH:Coronavirus Infections

30 A Randomized, Open-label, Controlled Study of the Efficacy of Lopinavir Plus Ritonavir and Arbidol for Treating With Patients With Novel Coronavirus Infection

The study explores the efficacy of lopinavir plus ritonavir and arbidol in treating with novel coronavirus infection. As a result this study would provide evidence for the clinical usage of these drugs in the future .

NCT04252885 Coronavirus Infections Drug: Lopinavir and Ritonavir Tablets Drug: Arbidol

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

31 Viral Excretion in Contact Subjects at High/Moderate Risk of Coronavirus 2019-nCoV Infection

In December 2019, a pneumonia due to a novel coronavirus (2019-nCoV) emerged in the city of Wuhan, in China. In a few weeks, the number of confirmed cases of 2019-nCoV infection has dramatically increased, with almost 20'000 cases and more than 400 reported deaths on January, 31st 2020. Little is known on the rate of human-to-human transmission of this new coronavirus 2019-nCoV. In France, subjects with contact considered to be at high or moderate risk of viral transmission with a laboratory-confirmed 2019-nCoV case are being isolated at their home for 14 days and followed up by Santé Publique France or the Agence Régionale de Santé. Whether such subjects become spreaders of the virus, nor is the proportion of viral spreader who will develop a symptomatic infection. In this study, the investigators aim to evaluate the virological and clinical outcomes of subjects following a contact at high/moderate risk of 2019-nCoV transmission. The study population is represented by all subjects who had a contact with laboratory-confirmed 2019-nCoV cases and whose contact was considered to be at high/moderate risk of 2019-nCoV transmission, as defined with precise criteria emitted by the Health Ministry and Santé Publique France. Procedures added by the research: Nasopharyngeal swabs for determination of the presence of 2019-nCoV detected by Polymerase Chain Reaction (PCR). Blood sampling for determination of the presence of 2019-nCoV type M immunoglobulins or type G immunoglobulins by microneutralisation technique.

NCT04259892 Coronavirus Biological: 2019-nCoV PCR

MeSH:Coronavirus Infections

32 A Randomized, Open-label, Multi-centre Clinical Trial Evaluating and Comparing the Safety and Efficiency of ASC09/Ritonavir and Lopinavir/Ritonavir for Confirmed Cases of Pneumonia Caused by Novel Coronavirus Infection

Base on Arbidol antiviral therapy,the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of ASC09 /ritonavir and lopinavir/ritonavir in patients with 2019-nCoV pneumonia.

NCT04261907 2019-nCoV Drug: ASC09/ritonavir group Drug: lopinavir/ritonavir group

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

33 Clinical Characterisation Protocol for Severe Emerging Infections

Infectious disease is the single biggest cause of death worldwide. New infectious agents, such as the SARS, MERS and other novel coronavirus, novel influenza viruses, viruses causing viral haemorrhagic fever (e.g. Ebola), and viruses that affect the central nervous system (CNS) such as TBEV & Nipah require investigation to understand pathogen biology and pathogenesis in the host. Even for known infections, resistance to antimicrobial therapies is widespread, and treatments to control potentially deleterious host responses are lacking. In order to develop a mechanistic understanding of disease processes, such that risk factors for severe illness can be identified and treatments can be developed, it is necessary to understand pathogen characteristics associated with virulence, the replication dynamics and in-host evolution of the pathogen, the dynamics of the host response, the pharmacology of antimicrobial or host-directed therapies, the transmission dynamics, and factors underlying individual susceptibility. The work proposed here may require sampling that will not immediately benefit the participants. It may also require analysis of the host genome, which may reveal other information about disease susceptibility or other aspects of health status.

NCT04262921 Coronavirus Infections

MeSH:Infection Communicable Diseases Coronavirus Infections Severe Acute Respiratory Syndrome

34 Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells in the Treatment of Severe COVID-19

The novel coronavirus pneumonia is a kind of new emerging respiratory infectious disease, characterized by fever, dry cough, and chest tightness, and caused by the infection of the 2019 novel coronavirus (2019-nCoV). In severe cases, there will be rapid respiratory system failure. The novel coronavirus pneumonia is extremely contagious and the disease progresses rapidly. It has become a urgent and serious public health event that threatens human life and health globally. Among them, severe pneumonia caused by novel coronavirus is characterized by extensive acute inflammation of the lungs and the patient is critically ill. At present, there is no effective treatment in clinical practice.Most of them should receive supportive care to help relieve symptoms. For severe cases, treatment should include care to support vital organ functions. This clinical trial is to inspect the safety and efficiency of Human Umbilical Cord Mesenchymal Stem Cells (UC-MSCs) therapy for severe pneumonia patients infected with 2019-nCoV.

NCT04273646 2019 Novel Coronavirus Pneumonia COVID-19 Biological: UC-MSCs Drug: Placebo

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

35 Evaluating the Efficacy and Safety of Bromhexine Hydrochloride Tablets Combined With Standard Treatment/ Standard Treatment in Patients With Suspected and Mild Novel Coronavirus Pneumonia (COVID-19)

Compare the efficacy and safety of Bromhexine Hydrochloride Tablets combined with standard treatment/ standard treatment in patients with suspected and mild, or common novel coronavirus pneumonia (COVID-19). Random, open, group sequential design.

NCT04273763 Novel Coronavirus Pneumonia 2019-nCoV Drug: Bromhexine Hydrochloride Tablets Drug: Arbidol Hydrochloride Granules Drug: Recombinant Human Interferon α2b Spray

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

36 Identifying Critically-ill Patients With COVID-19 Who Will Benefit Most From Nutrition Support Therapy: Validation of the NUTRIC Nutritional Risk Assessment Tool (COV_NUTRIC)

There was an interaction between mortality, nutritional intake and the Nutrition Risk in Critically ill (NUTRIC) score suggesting that those with higher NUTRIC scores benefited the most from increasing nutritional intake. Yet limited data were in Chinese patients. The current outbreak of novel coronavirus, named COVID-19, was first reported from Wuhan, China on Dec ember 31 , 2019. There are about 16% patients need ICU admission. The objective of this study is to validation of the "NUTRIC" nutritional risk assessment tool in Chinese ICU patients diagnosed as COVID-19.

NCT04274322 Critically Ill Coronavirus Infections Other: Nutrition support

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Critical Illness

37 A Prospective, Randomized, Open, Parallel Controlled, Multicenter Clinical Study of Xiyanping Injection in Combination With Conventional Treatment for the Evaluation of the Effectiveness and Safety of Novel Coronavirus Infection Pneumonia

the investigators conduct a randomized, open-label trial to evaluate and compare the safety and efficacy of Xiyanping injection in patients with 2019-nCoV pneumonia.

NCT04275388 2019 Novel Coronavirus Pneumonia Drug: Xiyanping injection Drug: Lopinavir / ritonavir, alpha-interferon nebulization

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

38 A Pilot Study of Bevacizumab in the Treatment of Severe or Critical Patients With COVID-19 Pneumonia (BEST-CP)

The novel identified coronavirus (SARS-CoV-2) in 2019 causes an nationwide outbreak as well as public health crisis in China, and expands globally. Pulmonary edema is one of the most detrimental symptoms and usually presents in severe and critical coronavirus disease (COVID-19), resulting in dyspnea, acute lung injury (ALI) ,acute respiratory distress syndrome (ARDS), and even death. Recent evidence revealed higher levels of blood Vascular Endothelial Growth Factor (VEGF) in COVID-19 patients compared with healthy controls. VEGF is considered as the most potent vascular permeability inducers. Numerous studies have revealed that VEGF was a key factor and a potential therapeutic target in ALI and ARDS. Bevacizumab, an anti-VEGF drug, approved by the FDA on February 26, 2004 and widely used in clinical oncotherapy, is a promising drug for ALI/ARDS in COVID-19 through suppression of pulmonary edema.

NCT04275414 Coronavirus Infections Drug: Bevacizumab Injection

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia

HPO:Pneumonia

39 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

40 A Pilot Clinical Study on Aerosol Inhalation of the Exosomes Derived From Allogenic Adipose Mesenchymal Stem Cells in the Treatment of Severe Patients With Novel Coronavirus Pneumonia

In December 2019, a novel coronavirus infectious disease characterized by acute respiratory impairment due to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) broke out in Wuhan city of Hubei province in China. So far no specific antiviral therapy can be available for patients with SARS-CoV-2 infection. Although symptomatic and supportive care, even with mechanical ventilation or extracorporeal membrane oxygenation (ECMO), are strongly recommended for severe infected individuals, those with advancing age and co-morbidities such as diabetes and heart disease remain to be at high risk for adverse outcomes. This pilot clinical trial will be performed to explore the safety and efficiency of aerosol inhalation of the exosomes derived from allogenic adipose mesenchymal stem cells (MSCs-Exo) in severe patients with novel coronavirus pneumonia (NCP).

NCT04276987 Coronavirus Biological: MSCs-derived exosomes

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

41 Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs

The study investigators are interested in learning more about how drugs, that are given to children by their health care provider, act in the bodies of children and young adults in hopes to find the most safe and effective dose for children. The primary objective of this study is to evaluate the PK of understudied drugs currently being administered to children per SOC as prescribed by their treating provider.

NCT04278404 Coronavirus Infection (COVID-19) Pulmonary Arterial Hypertension Urinary Tract Infections in Children Hypertension Pain Hyperphosphatemia Primary Hyperaldosteronism Edema Hypokalemia Heart Failure Hemophilia Prior to Tooth Extraction Menorrhagia Insomnia Pneumonia Skin Infection Arrythmia Asthma in Children Bronchopulmonary Dysplasia Adrenal Insufficiency Hypertension, Resistant to Conventional Therapy Fibrinolysis; Hemorrhage Drug: The POP02 study is collecting bodily fluid samples (i.e., whole blood, effluent samples) of children prescribed the following drugs of interest per standard of care:

MeSH:Infection Communicable Diseases Urinary Tract Infections Coronavirus Infections Severe Acute Respiratory Syndrome Bronchopulmonary Dysplasia Menorrhagia Hypertension Hyperphosphatemia Hypokalemia Adrenal Insufficiency Hyperaldosteronism Hemorrhage

HPO:Adrenal insufficiency Hyperaldosteronism Hyperphosphatemia Hypertension Hypokalemia Menorrhagia Primary hyperaldosteronism

42 Investigation on Clinical Features of Suspected and Confirmed Patients of 2019 Novel Coronavirus Infection in Isolation Unit

Outbreak of 2019 Novel Coronavirus infection started in Wuhan and quickly spread to the world. Suspected patients were isolated and treated in our department. Clinical data was recorded to investigate the clinical features of patients confirmed and excluded diagnosed of 2019 Novel Coronavirus infection.

NCT04279782 Coronavirus Other: Comprehensive treatment

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome

43 Study on Detection of 2019 Novel Coronavirus in Multiple Organ System and Its Relationship With Clinical Manifestations in Patients

Outbreak of 2019 Novel Coronavirus infection quickly spread to the world. Confirmed patients were isolated and treated in our department. 2019 Novel Coronavirus was detected in multiple organ system. Clinical data was recorded to investigate the its relationship with viral detection.

NCT04279795 Coronavirus

MeSH:Coronavirus Infections

44 Clinical Investigation of Natural Killer Cells Treatment in Pneumonia Patients Infected With 2019 Novel Coronavirus

Since december 2019, acute respiratory disease due to 2019 novel coronavirus (2019-nCoV) emerged in Wuhan city and rapidly spread throughout China. There is no confirmed antivirus therapy for 2019-nCoV infection. Natural killer (NK) cells are innate lymphocytes that may serve as useful effectors against danger infection. The purpose of this clinical investigation is to evaluate the safety and efficiency of NK Cells in combination with standard therapy for pneumonia patients infected with 2019-nCoV.

NCT04280224 Novel Coronavirus Pneumonia Biological: NK Cells

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

45 Efficacy of Fingolimod in the Treatment of New Coronavirus Pneumonia (COVID-19)

Although immune-inflammatory treatment is not routinely recommended to be used for SARS-CoV-2 pneumonia, according to the pathological findings of pulmonary oedema and hyaline membrane formation, timely and appropriate use of immune modulator together with ventilator support should be considered for the severe patients to prevent ARDS development. The sphingosine-1-phosphate receptor regulators Fingolimod (FTY720) is an effective immunology modulator which has been widely used in multiple sclerosis.The aim of this study was to determine whether the efficacy of fingolimod for a novel coronavirus disease (COVID-19).

NCT04280588 Coronavirus Disease (COVID-19) Drug: Fingolimod 0.5 mg

MeSH:Coronavirus Infections

46 A Multicenter, Adaptive, Randomized Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for the Treatment of COVID-19 in Hospitalized Adults

This study is an adaptive, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of novel therapeutic agents in hospitalized adults diagnosed with COVID-19. The study is a multicenter trial that will be conducted in up to approximately 100 sites globally. The study will compare different investigational therapeutic agents to a control arm. There will be interim monitoring to introduce new arms and allow early stopping for futility, efficacy, or safety. If one therapy proves to be efficacious, then this treatment may become the control arm for comparison(s) with new experimental treatment(s). Any such change would be accompanied by an updated sample size. Because background standards of supportive care may evolve/improve over time as more is learned about successful management of COVID-19, comparisons of safety and efficacy will be based on data from concurrently randomized subjects. An independent Data and Safety Monitoring Board (DSMB) will actively monitor interim data to make recommendations about early study closure or changes to study arms. To evaluate the clinical efficacy, as assessed by time to recovery, of different investigational therapeutics as compared to the control arm.

NCT04280705 Corona Virus Infection Other: Placebo Drug: Remdesivir

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases

47 Clinical Outcomes of Hospitalized Patients With Coronavirus Disease 2019

As of February 17th, 2020, China has 70635 confirmed cases of coronavirus disease 2019 (COVID-19), including 1772 deaths. Human-to-human spread of virus via respiratory droplets is currently considered to be the main route of transmission. The number of patients increased rapidly but the impact factors of clinical outcomes among hospitalized patients are still unclear.

NCT04280913 Coronavirus Disease 2019 Other: retrospective analysis

MeSH:Coronavirus Infections

48 Identification of a New Screening Strategy for 2019 Novel Coronavirus Infection

Since Dec 2019, over 70000 novel coronavirus infection pneumonia (NCIP) patients were confirmed. 2019 novel coronavirus (2019 nCoV) is a RNA virus, which spread mainly from person-to-person contact. Most of the symptoms are non-specific, including fever, fatigue, dry cough. Sever NCIP patients may have shortness of breath and dyspnea, and progress to acute respiratory distress syndrome (ARDS) and multiple organ dysfunction syndrome (MODS). The mortality is reported to be around 2.3%. Thus, early detection and early treatment is very important to the improvement of NCIP patients' prognosis. At present, NCIP RNA detection of pharyngeal swab specimen by RT-PCR is recommended. However, due to the universal susceptibility to 2019 nCoV in general population and limited number of NCIP RNA detection kits available, to identify an efficient screening strategy is urgently needed. This study aim to develop and validate the diagnostic accuracy and screening efficiency of a new NCIP screening strategy, which can benefit the disease prevention and control.

NCT04281693 Novel Coronavirus Infection Pneumonia Diagnostic Test: Standard screening strategy Diagnostic Test: New screening strategy

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

HPO:Pneumonia

49 A Randomized, Open-label Study to Evaluate the Efficacy and Safety of Pirfenidone in Patients With Severe and Critical Novel Coronavirus Infection

The acute lung injury caused by SARS and 2003 were both related to the inflammatory cytokine storm in patients. The biochemical test showed abnormal increase in related indicators such as interleukin-8, and CT images showed a medical "white" lung". According to the experience of SARS treatment in 2003, the use of hormones will indeed help the patients to alleviate their illness, but patients who survived SARS either had too much hormone at that time and took too long. Although the lungs could recover, but the femoral head was necrotic Either the amount of hormones was very conservative at the time, which kept the lungs in the storm of inflammatory factors, leading to the emergence of irreversible pulmonary fibrosis. So is there a medicine that can anti-inflammatory, reduce the load of hormone use, and have the effect of treating and preventing pulmonary fibrosis complicated by severe viral lung? At present, pirfenidone has achieved encouraging results in the treatment of idiopathic Pulmonary Fibrosis (CTD-ILD) diseases. It is particularly encouraging that the values announced at the 2019 ATS Annual Conference suggest that pirfenidone has more anti-inflammatory and anti-oxidant effects than its own outstanding anti-fibrotic ability. The data shows early use, Its strong anti-SOD activity can effectively inhibit IL-1beta and IL-4, and can open the prevention mode of pulmonary interstitial fibrosis. Based on the above, this project intends to make the following scientific assumptions: based on the homology of the pathogens of the new coronavirus-infected pneumonia and the coronavirus infection of pneumonia in 2003, the similarities in the occurrence and development of the disease, that is, the pulmonary inflammatory storm occurs first, and thereafter The progress of fibrosis and the progressive decline of lung function and mortality are higher than those of ordinary pneumonia. We hope that by adding pirfenidone as a treatment program in addition to standard treatment, it will be a new and severe type of coronavirus infection. Patient clinical treatment provides an effective and practical method.

NCT04282902 Novel Coronavirus Pneumonia Pneumonia Pirfenidone Drug: pirfenidone

MeSH:Coronavirus Infections Severe Acute Respiratory Syndrome Pneumonia

HPO:Pneumonia

50 Study for Clinical Epidemiology and Methods of Diagnosis and Treatment of Novel Coronavirus Pneumonia (NCP)

To develop practical and effective clinical diagnosis and treatment schemes for the control of novel coronavirus pneumonia.

NCT04283396 Novel Coronavirus Pneumonia Combination Product: systemic treatment

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

51 Phase I, Open-Label, Dose-Ranging Study of the Safety and Immunogenicity of 2019-nCoV Vaccine (mRNA-1273) in Healthy Adults

This is a phase I, open-label, dose ranging clinical trial in males and non-pregnant females, 18 to 55 years of age, inclusive, who are in good health and meet all eligibility criteria. This clinical trial is designed to assess the safety, reactogenicity and immunogenicity of mRNA-1273 manufactured by ModernaTX, Inc. mRNA-1273 is a novel lipid nanoparticle (LNP)-encapsulated mRNA-based vaccine that encodes for a full-length, prefusion stabilized spike (S) protein of SARS-CoV-2. Enrollment will occur at one domestic site. Forty-five subjects will be enrolled into one of three cohorts and will receive an intramuscular (IM) injection of mRNA-1273 on Days 1 and 29 in the deltoid muscle. Subjects will be followed through 12 months post second vaccination (Day 394). The primary objective is to evaluate the safety and reactogenicity of a 2-dose vaccination schedule of mRNA-1273, given 28 days apart, across 3 dosages in healthy adults.

NCT04283461 Corona Virus Infection Immunisations Biological: mRNA-1273

MeSH:Infection Coronavirus Infections Severe Acute Respiratory Syndrome Virus Diseases

52 The Therapeutic Efficacy of Psychological and Physical Rehabilitation Based Humanistic Care in Patients With Coronavirus Disease 2019

As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. Although the impact factors of clinical outcomes among hospitalized patients still need to be clarified, some of the therapeutic regimens have shown the potency in the treatment of severe cases. Investigators aim to evaluate the efficacy of psychological and physical rehabilitation based humanistic care in the treatment of COVID-2019.

NCT04283825 Coronavirus Disease 2019 Behavioral: Psychological and physical rehabilitation based humanistic care

MeSH:Coronavirus Infections

53 The Effect of Humanistic Care in Healthcare Workers Participated in the Treatment of Coronavirus Disease 2019

As of February 17th, 2020, China has 76396 confirmed cases of coronavirus disease 2019 (COVID-19), including 2348 deaths. The impact factors of clinical outcomes among hospitalized patients still need to be clarified. The healthcare workers faced greater mental and physical pressure under long-term, high-intensity, high-risk working conditions. Investigators aim to evaluate the positive effect of humanistic care for healthcare workers participated in the treatment of COVID-19.

NCT04283838 Coronavirus Disease 2019 Behavioral: Humanistic Care

MeSH:Coronavirus Infections

54 A Clinical Study to Investigate the Effect of T89 on Improving Oxygen Saturation and Clinical Symptoms in Patients With Coronavirus Disease 2019 (COVID-19)

This is an open-label, randomized, blank-controlled treatment clinical study. The objective of this study is to investigate the effect of T89 on improving oxygen saturation and clinical symptoms in patients with Coronavirus Disease 2019 (COVID-19). In this study, estimated total of 120-240 male and female patients who have been diagnosed with non-critical type of coronavirus pneumonia (COVID-19) will be enrolled and randomly assigned to one of two study groups, the T89 treatment group and the blank control group, to T89 or nothing on the base of a recommended standard treatment for up to 14 days . The primary efficacy parameters include the time to oxygen saturation recovery to normal level (≥97%), the proportion of patients with normal level of oxygen saturation after treatment, and the total duration of oxygen inhalation, oxygen flow change by time, oxygen concentration change by time during treatment.

NCT04285190 Coronavirus Disease 2019 Novel Coronavirus Pneumonia Drug: T89

MeSH:Coronavirus Infections Pneumonia

HPO:Pneumonia

55 The Efficacy and Safety of Carrimycin Treatment in Patients With Novel Coronavirus Infectious Disease (COVID-19) : A Multicenter, Randomized, Open-controlled Study

The novel coronavirus infectious disease ( COVID-19") induced by novel coronavirus(SARS-CoV-2) in December 2019 has outbreaked in Wuhan. It may lead to epidemic risk in global. As the COVID-19 is an emerging infectious disease, it has not scientifically recognized and has no effective drugs for treatment currently. Therefore, we will launch a scientific project "The efficacy and safety of carrimycin treatment in 520 patients with COVID-19 stratificated clinically: A multicenter, randomized (1:1), open-controlled (one of lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate) study" . We try to establish the criteria for clinical cure and the early predictive model of COVID-19 progression. The primary efficiency outcomes were:(1) Fever to normal time (day); (2) Pulmonary inflammation resolution time (HRCT) (day); and (3)Negative conversion (%) of SARS-CoV-2 RNA at the end of treatment. The secondary efficiency outcomes and adverse events were observed.

NCT04286503 Novel Coronavirus Infectious Disease (COVID-19) Drug: Carrimycin Drug: lopinavir/ritonavir tablets or Arbidol or chloroquine phosphate Drug: basic treatment

MeSH:Communicable Diseases Infection Coronavirus Infections