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1.
EuropePMC; 2021.
Preprint in English | EuropePMC | ID: ppcovidwho-314622

ABSTRACT

Shortages of personal protective equipment for use during the SARS-CoV-2 pandemic continue to be an issue among health-care workers globally. Extended and repeated use of N95 filtering facepiece respirators without adequate decontamination is of particular concern. Although several methods to decontaminate and re-use these masks have been proposed, logistic or practical issues limit adoption of these techniques. In this study, we propose and validate the use of the application of moist heat (70 o C with humidity augmented by an open pan of water) applied by commonly available hospital (blanket) warming cabinets to decontaminate N95 masks. This report shows that a variety of N95 masks can be repeatedly decontaminated of SARS-CoV-2 over 6 hours moist heat exposure without compromise of their filtering function as assessed by standard fit and sodium chloride aerosol filtration efficiency testing. This approached can easily adapted to provide point-of-care N95 mask decontamination allowing for increased practical utility of mask recycling in the health care setting.

2.
Crit Care ; 26(1): 10, 2022 01 04.
Article in English | MEDLINE | ID: covidwho-1604921

ABSTRACT

BACKGROUND: Research on the duration of infectivity of ICU patients with COVID-19 has been sparse. Tests based on Reverse Transcriptase polymerase chain reaction (RT-PCR) detect both live virus and non-infectious viral RNA. We aimed to determine the duration of infectiousness based on viral culture of nasopharyngeal samples of patients with COVID-19. METHODS: Prospective observational study in adult intensive care units with a diagnosis of COVID-19 Pneumonia. Patients had repeated nasopharyngeal sampling performed after day 10 of ICU admission. Culture positive rate (based on viral culture on Vero cells in a level 4 lab) and Cycle threshold from RT-PCR were measured. RESULTS: Nine patients of the 108 samples (8.3%, 95% CI 3.9-15.2%) grew live virus at a median of 13 days (interquartile range 11-19) after their initial positive test. 74.1% of patients were RT-PCR positive but culture negative, and the remaining (17.6%) were RT-PCR and culture negative. Cycle threshold showed excellent ability to predict the presence of live virus, with a Ct < 25 with an AUC of 0.90 (95% CI 0.83-0.97, p < 0.001). The specificity of a Ct > 25 to predict negative viral culture was 100% (95% CI 70-100%). CONCLUSION: 8.3% of our ICU patients with COVID-19 grew live virus at a median of 13 days post-initial positive RT-PCR test. Severity of illness, use of mechanical ventilation, and time between tests did not predict the presence of live virus. Cycle threshold of > 25 had the best ability to determine the lack of live virus in these patents.


Subject(s)
COVID-19 , SARS-CoV-2 , Adult , COVID-19/therapy , COVID-19/virology , COVID-19 Nucleic Acid Testing , Critical Illness , Humans , Intensive Care Units , Nasopharynx/virology , Prospective Studies , SARS-CoV-2/isolation & purification
3.
1st International Conference on AI-ML-Systems, AIMLSystems 2021 ; 2021.
Article in English | Scopus | ID: covidwho-1504233

ABSTRACT

The spread of Covid-19 virus around the world has taken many lives, quarantined people and shattered many industries. Due to high transmissibility of the virus and its silent incubation period in human beings, detection of the virus plays an important role to control its spread and to plan diagnostic and preventive measures. Laboratory tests such as Polymerase Chain Reaction (PCR) take more time and hence there is a need for rapid and accurate diagnostic methods to detect the virus to prevent its spread and combat it. Today PCR tests were used for diagnosing purposes and the chest x-ray was only used as the follow up of patients, hence these studies on the chest x-rays of patients with Covid-19 pneumonia or any other disease are still limited to the literature and must be improved in the future. In this project, the goal is to build an application for healthcare workers to monitor the health of lungs using the chest x-ray images of patients. The algorithm must be very accurate because it deals with the lives of people. Here we used computer vision and deep learning techniques in this project. The focus is to classify chest x-ray images and segment the abnormal region and to get more insights on the images from the available datasets. The diagnostic accuracy is the challenging part and to increase the detection efficiency due to the limited open-source data available. The data was collected from the internet. On classification, the trained model was able to achieve 93.10% accuracy and F1 Score of 0.93 after using transfer learning technique with pneumonia images. On segmentation, the Intersection Over Union value was found to be 0.91 on the validation data. © 2021 ACM.

4.
Neurol India ; 69(5): 1234-1240, 2021.
Article in English | MEDLINE | ID: covidwho-1502576

ABSTRACT

BACKGROUND: Globally, social distancing has been practiced during the ongoing coronavirus disease 2019 (COVID-19) pandemic to prevent the transmission of the virus. One of the measures to ensure social distancing and restricting the movements has been national lockdown, to break the chain of transmission. Telemedicine is a cost-effective measure to provide medical services to remote underserved areas. OBJECTIVE: The present study aimed to evaluate the efficacy and acceptability of teleconsultation as an alternative option to in-person consultation in providing continued medical care for neurology patients during the national lockdown period of the COVID-19 pandemic. MATERIALS AND METHODS: The clinical demographic profile, frequency of different neurological disorders, and treatment details of the patients attending the teleneurology consultation (TNCO) outpatient department (OPD) at Sir Sunderlal Hospital (S.S.H.), Institute of Medical Sciences (I.M.S.), BHU, Varanasi, India, were recorded in a prespecified pro forma. RESULTS: A total of 1,567 patients attended the TNCO OPD over 90 days. The average patient attendance was 35 per day, and 72% were males. Out of these, 77% of patients were from the same district, and the majority of patients (68%) were regularly followed up in-person by the neurology OPD. The most common illness for consultation was epilepsy (19%) followed by low backache and stroke (18% each). The satisfaction rate among the patients with respect to teleservices was high (90%). CONCLUSION: TNCO seems to be as effective as in-person OPD in the management of neurological disorders. During the lockdown due to the COVID-19 pandemic, avoiding physical visits through TNCO may reduce the spread of the virus. Parallel tele-OPD with routine OPD is a good option in the future.


Subject(s)
COVID-19 , Epilepsy , Neurology , Remote Consultation , Communicable Disease Control , Humans , Male , Pandemics , SARS-CoV-2 , Telephone
5.
Crit Care Med ; 49(11): 1974-1982, 2021 11 01.
Article in English | MEDLINE | ID: covidwho-1475880
6.
PLoS One ; 16(9): e0258151, 2021.
Article in English | MEDLINE | ID: covidwho-1443858

ABSTRACT

BACKGROUND: Few studies have quantified aerosol concentrations of SARS-CoV-2 in hospitals and long-term care homes, and fewer still have examined samples for viability. This information is needed to clarify transmission risks beyond close contact. METHODS: We deployed particulate air samplers in rooms with COVID-19 positive patients in hospital ward and ICU rooms, rooms in long-term care homes experiencing outbreaks, and a correctional facility experiencing an outbreak. Samplers were placed between 2 and 3 meters from the patient. Aerosol (small liquid particles suspended in air) samples were collected onto gelatin filters by Ultrasonic Personal Air Samplers (UPAS) fitted with <2.5µm (micrometer) and <10 µm size-selective inlets operated for 16 hours (total 1.92m3), and with a Coriolis Biosampler over 10 minutes (total 1.5m3). Samples were assayed for viable SARS-CoV-2 virus and for the viral genome by multiplex PCR using the E and N protein target sequences. We validated the sampling methods by inoculating gelatin filters with viable vesicular stomatitis virus (VSV), and with three concentrations of viable SARS-CoV-2, operating personal samplers for 16hrs, and quantifying viable virus recovery by TCID50 assay. RESULTS: In total, 138 samples were collected from 99 rooms. RNA samples were positive in 9.1% (6/66) of samples obtained with the UPAS 2.5µm samplers, 13.5% (7/52) with the UPAS 10µm samplers, and 10.0% (2/20) samples obtained with the Coriolis samplers. Culturable virus was not recovered in any samples. Viral RNA was detected in 15.1% of the rooms sampled. There was no significant difference in viral RNA recovery between the different room locations or samplers. Method development experiments indicated minimal loss of SARS-CoV-2 viability via the personal air sampler operation.


Subject(s)
Aerosols/isolation & purification , Air Microbiology , COVID-19/virology , SARS-CoV-2/isolation & purification , Animals , COVID-19/epidemiology , COVID-19/transmission , Chlorocebus aethiops , Hospitals , Humans , Long-Term Care , RNA, Viral/isolation & purification , Vero Cells
7.
Sci Rep ; 11(1): 18316, 2021 09 15.
Article in English | MEDLINE | ID: covidwho-1412847

ABSTRACT

Shortages of personal protective equipment for use during the SARS-CoV-2 pandemic continue to be an issue among health-care workers globally. Extended and repeated use of N95 filtering facepiece respirators without adequate decontamination is of particular concern. Although several methods to decontaminate and re-use these masks have been proposed, logistic or practical issues limit adoption of these techniques. In this study, we propose and validate the use of the application of moist heat (70 °C with humidity augmented by an open pan of water) applied by commonly available hospital (blanket) warming cabinets to decontaminate N95 masks. This report shows that a variety of N95 masks can be repeatedly decontaminated of SARS-CoV-2 over 6 h moist heat exposure without compromise of their filtering function as assessed by standard fit and sodium chloride aerosol filtration efficiency testing. This approached can easily adapted to provide point-of-care N95 mask decontamination allowing for increased practical utility of mask recycling in the health care setting.


Subject(s)
Decontamination/methods , N95 Respirators/virology , SARS-CoV-2/physiology , Equipment Reuse , Hospitals , Humans , Humidity , Point-of-Care Systems , Time Factors , Virus Inactivation
9.
N Engl J Med ; 385(9): 790-802, 2021 Aug 26.
Article in English | MEDLINE | ID: covidwho-1343498

ABSTRACT

BACKGROUND: Thrombosis and inflammation may contribute to the risk of death and complications among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation may improve outcomes in noncritically ill patients who are hospitalized with Covid-19. METHODS: In this open-label, adaptive, multiplatform, controlled trial, we randomly assigned patients who were hospitalized with Covid-19 and who were not critically ill (which was defined as an absence of critical care-level organ support at enrollment) to receive pragmatically defined regimens of either therapeutic-dose anticoagulation with heparin or usual-care pharmacologic thromboprophylaxis. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. This outcome was evaluated with the use of a Bayesian statistical model for all patients and according to the baseline d-dimer level. RESULTS: The trial was stopped when prespecified criteria for the superiority of therapeutic-dose anticoagulation were met. Among 2219 patients in the final analysis, the probability that therapeutic-dose anticoagulation increased organ support-free days as compared with usual-care thromboprophylaxis was 98.6% (adjusted odds ratio, 1.27; 95% credible interval, 1.03 to 1.58). The adjusted absolute between-group difference in survival until hospital discharge without organ support favoring therapeutic-dose anticoagulation was 4.0 percentage points (95% credible interval, 0.5 to 7.2). The final probability of the superiority of therapeutic-dose anticoagulation over usual-care thromboprophylaxis was 97.3% in the high d-dimer cohort, 92.9% in the low d-dimer cohort, and 97.3% in the unknown d-dimer cohort. Major bleeding occurred in 1.9% of the patients receiving therapeutic-dose anticoagulation and in 0.9% of those receiving thromboprophylaxis. CONCLUSIONS: In noncritically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin increased the probability of survival to hospital discharge with reduced use of cardiovascular or respiratory organ support as compared with usual-care thromboprophylaxis. (ATTACC, ACTIV-4a, and REMAP-CAP ClinicalTrials.gov numbers, NCT04372589, NCT04505774, NCT04359277, and NCT02735707.).


Subject(s)
Anticoagulants/administration & dosage , COVID-19/drug therapy , Heparin/administration & dosage , Thrombosis/prevention & control , Adult , Aged , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , COVID-19/mortality , Female , Hemorrhage/chemically induced , Heparin/adverse effects , Heparin/therapeutic use , Heparin, Low-Molecular-Weight/therapeutic use , Hospital Mortality , Humans , Male , Middle Aged , Survival Analysis
10.
N Engl J Med ; 385(9): 777-789, 2021 Aug 26.
Article in English | MEDLINE | ID: covidwho-1343497

ABSTRACT

BACKGROUND: Thrombosis and inflammation may contribute to morbidity and mortality among patients with coronavirus disease 2019 (Covid-19). We hypothesized that therapeutic-dose anticoagulation would improve outcomes in critically ill patients with Covid-19. METHODS: In an open-label, adaptive, multiplatform, randomized clinical trial, critically ill patients with severe Covid-19 were randomly assigned to a pragmatically defined regimen of either therapeutic-dose anticoagulation with heparin or pharmacologic thromboprophylaxis in accordance with local usual care. The primary outcome was organ support-free days, evaluated on an ordinal scale that combined in-hospital death (assigned a value of -1) and the number of days free of cardiovascular or respiratory organ support up to day 21 among patients who survived to hospital discharge. RESULTS: The trial was stopped when the prespecified criterion for futility was met for therapeutic-dose anticoagulation. Data on the primary outcome were available for 1098 patients (534 assigned to therapeutic-dose anticoagulation and 564 assigned to usual-care thromboprophylaxis). The median value for organ support-free days was 1 (interquartile range, -1 to 16) among the patients assigned to therapeutic-dose anticoagulation and was 4 (interquartile range, -1 to 16) among the patients assigned to usual-care thromboprophylaxis (adjusted proportional odds ratio, 0.83; 95% credible interval, 0.67 to 1.03; posterior probability of futility [defined as an odds ratio <1.2], 99.9%). The percentage of patients who survived to hospital discharge was similar in the two groups (62.7% and 64.5%, respectively; adjusted odds ratio, 0.84; 95% credible interval, 0.64 to 1.11). Major bleeding occurred in 3.8% of the patients assigned to therapeutic-dose anticoagulation and in 2.3% of those assigned to usual-care pharmacologic thromboprophylaxis. CONCLUSIONS: In critically ill patients with Covid-19, an initial strategy of therapeutic-dose anticoagulation with heparin did not result in a greater probability of survival to hospital discharge or a greater number of days free of cardiovascular or respiratory organ support than did usual-care pharmacologic thromboprophylaxis. (REMAP-CAP, ACTIV-4a, and ATTACC ClinicalTrials.gov numbers, NCT02735707, NCT04505774, NCT04359277, and NCT04372589.).


Subject(s)
Anticoagulants/administration & dosage , COVID-19/drug therapy , Heparin/administration & dosage , Thrombosis/prevention & control , Aged , Anticoagulants/adverse effects , Anticoagulants/therapeutic use , COVID-19/mortality , Critical Illness , Female , Hemorrhage/chemically induced , Heparin/adverse effects , Heparin/therapeutic use , Hospital Mortality , Humans , Logistic Models , Male , Middle Aged , Odds Ratio , Respiration, Artificial , Treatment Failure
13.
Vaccine ; 38(34): 5418-5423, 2020 07 22.
Article in English | MEDLINE | ID: covidwho-1135582

ABSTRACT

The World Health Organization declared the COVID-19 disease as a pandemic requiring a rapid response. Through online search, direct communication with network members and an internal survey, engagements of developing countries' vaccine manufacturers' network members in the research and development of COVID-19 vaccines and their capacities in the manufacturing, fill-finish and distribution of vaccines were assessed. Currently, 19 network members engaged in research and development of COVID-19 vaccines, using six principal technology platforms. In addition, an internal survey showed that the number of vaccines supplied collectively by 37 members, in 2018-19, was about 3.5 billion doses annually. Almost a third of network members having vaccines prequalified by the World Health Organization comply with international regulations and mechanisms to distribute vaccines across borders. The use of existing manufacturing, fill-finish and distribution capabilities can support an efficient roll-out of vaccines against COVID-19, while maintaining supply security of existing vaccines for on-going immunization programmes.


Subject(s)
Biomedical Research/organization & administration , Coronavirus Infections , Drug Industry/organization & administration , International Cooperation , Pandemics , Pneumonia, Viral , Viral Vaccines/supply & distribution , COVID-19 , COVID-19 Vaccines , Clinical Trials as Topic , Coronavirus Infections/immunology , Coronavirus Infections/prevention & control , Humans , Pandemics/prevention & control , Pneumonia, Viral/prevention & control , Viral Vaccines/immunology , World Health Organization
14.
PLoS One ; 15(12): e0243965, 2020.
Article in English | MEDLINE | ID: covidwho-978945

ABSTRACT

The response to the COVID-19 epidemic is generating severe shortages of personal protective equipment around the world. In particular, the supply of N95 respirator masks has become severely depleted, with supplies having to be rationed and health care workers having to use masks for prolonged periods in many countries. We sought to test the ability of 7 different decontamination methods: autoclave treatment, ethylene oxide gassing (ETO), low temperature hydrogen peroxide gas plasma (LT-HPGP) treatment, vaporous hydrogen peroxide (VHP) exposure, peracetic acid dry fogging (PAF), ultraviolet C irradiation (UVCI) and moist heat (MH) treatment to decontaminate a variety of different N95 masks following experimental contamination with SARS-CoV-2 or vesicular stomatitis virus as a surrogate. In addition, we sought to determine whether masks would tolerate repeated cycles of decontamination while maintaining structural and functional integrity. All methods except for UVCI were effective in total elimination of viable virus from treated masks. We found that all respirator masks tolerated at least one cycle of all treatment modalities without structural or functional deterioration as assessed by fit testing; filtration efficiency testing results were mostly similar except that a single cycle of LT-HPGP was associated with failures in 3 of 6 masks assessed. VHP, PAF, UVCI, and MH were associated with preserved mask integrity to a minimum of 10 cycles by both fit and filtration testing. A similar result was shown with ethylene oxide gassing to the maximum 3 cycles tested. Pleated, layered non-woven fabric N95 masks retained integrity in fit testing for at least 10 cycles of autoclaving but the molded N95 masks failed after 1 cycle; filtration testing however was intact to 5 cycles for all masks. The successful application of autoclaving for layered, pleated masks may be of particular use to institutions globally due to the virtually universal accessibility of autoclaves in health care settings. Given the ability to modify widely available heating cabinets on hospital wards in well-resourced settings, the application of moist heat may allow local processing of N95 masks.


Subject(s)
Decontamination/methods , Equipment Reuse , N95 Respirators/virology , COVID-19/pathology , COVID-19/virology , Ethylene Oxide/pharmacology , Humans , Hydrogen Peroxide/pharmacology , Peracetic Acid/pharmacology , Plasma Gases/pharmacology , SARS-CoV-2/drug effects , SARS-CoV-2/isolation & purification , SARS-CoV-2/radiation effects , Ultraviolet Rays , Vesiculovirus/drug effects , Vesiculovirus/radiation effects
15.
J Policy Model ; 43(1): 76-94, 2021.
Article in English | MEDLINE | ID: covidwho-894067

ABSTRACT

The rising number of COVID-19 cases and economic implications of lockdown measures indicate the tricky balancing act policy makers face as they implement the subsequent phases of 'unlock'. We develop a model to examine how lockdown and social distancing measures have influenced the behavioral conduct of people. The current situation highlights that policy makers need to focus on bringing awareness and social restraint among people rather than going for stringent lockdown measures. We believe this work will help the policy makers gain insights into the troubled COVID-19 times ahead, and based on the estimates, they can frame policies to navigate these wild waves in the best possible way.

16.
Neurol Sci ; 41(12): 3437-3470, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-888212

ABSTRACT

BACKGROUND: Coronaviruses mainly affect the respiratory system; however, there are reports of SARS-CoV and MERS-CoV causing neurological manifestations. We aimed at discussing the various neurological manifestations of SARS-CoV-2 infection and to estimate the prevalence of each of them. METHODS: We searched the following electronic databases; PubMed, MEDLINE, Scopus, EMBASE, Google Scholar, EBSCO, Web of Science, Cochrane Library, WHO database, and ClinicalTrials.gov . Relevant MeSH terms for COVID-19 and neurological manifestations were used. Randomized controlled trials, non-randomized controlled trials, case-control studies, cohort studies, cross-sectional studies, case series, and case reports were included in the study. To estimate the overall proportion of each neurological manifestations, the study employed meta-analysis of proportions using a random-effects model. RESULTS: Pooled prevalence of each neurological manifestations are, smell disturbances (35.8%; 95% CI 21.4-50.2), taste disturbances (38.5%; 95%CI 24.0-53.0), myalgia (19.3%; 95% CI 15.1-23.6), headache (14.7%; 95% CI 10.4-18.9), dizziness (6.1%; 95% CI 3.1-9.2), and syncope (1.8%; 95% CI 0.9-4.6). Pooled prevalence of acute cerebrovascular disease was (2.3%; 95%CI 1.0-3.6), of which majority were ischaemic stroke (2.1%; 95% CI 0.9-3.3), followed by haemorrhagic stroke (0.4%; 95% CI 0.2-0.6), and cerebral venous thrombosis (0.3%; 95% CI 0.1-0.6). CONCLUSIONS: Neurological symptoms are common in SARS-CoV-2 infection, and from the large number of cases reported from all over the world daily, the prevalence of neurological features might increase again. Identifying some neurological manifestations like smell and taste disturbances can be used to screen patients with COVID-19 so that early identification and isolation is possible.


Subject(s)
Central Nervous System Diseases/epidemiology , Central Nervous System Diseases/virology , Coronavirus Infections/complications , Pneumonia, Viral/complications , Betacoronavirus , COVID-19 , Humans , Pandemics , Prevalence , SARS-CoV-2
17.
Preprint in English | medRxiv | ID: ppmedrxiv-20195958

ABSTRACT

Prone position ventilation has been shown to decrease mortality and improve oxygenation in ARDS patients. With best of our knowledge, no study reported physiological effect of prone position in SARS-CoV-2 infected ARDS patients. In this prospective observational study, data of n=20 consecutive laboratory confirmed SARS-CoV-2 patients with severe ARDS as per Berlin definition was included. Data of 20 patients analyzed with a median (Interquartile range, IQR) age of 56 (45.5-67) y and median (IQR) P/F ratio of 56 (54-66) with a median (IQR) PEEP of 12 (12-14) before initiation of prone position. Seventy-five percentage (95% CI 53.1-88.8) patients were prone responders at 16h prone session and 50 (95% CI 29.9-70.1) % patients were sustained responders. There was a significant decrease in plateau airway pressure (p<0.0001), peak airway pressure (p<0.0001) and driving pressure(p<0.0001) and increase in static compliance (p=0.001), P/F ratio (p<0.0001), PaO2 (p=0.0002)and SpO2 (p=0.0004) at 4h and 16h since initiation of prone session and also after return of supine position. Prone position in SARS-CoV-2 infected severe ARDS patients is associated with improvement in lung compliance and oxygenation in two-third of the patients and persisted in half of the patients.

18.
Preprint in English | medRxiv | ID: ppmedrxiv-20184028

ABSTRACT

Early reports from China and Europe indicated that incidence of venous thromboembolism in COVID-19 patients may be high. In this meta-analysis of observational studies was designed to know worldwide prevalence of thromboembolic events in COVID-19 patients. Primary outcome of our review was to assess the proportion of patients with VTE. Secondary outcomes were to assess the proportion of patients with DVT and proportion of patients with PE. Random effect meta-analysis model with restricted maximum likelihood estimator was used for all analysis. Pooled proportion with 95% confidence interval (95% CI) and heterogeneity (I2) was reported for all outcomes. Data of 5426 patients from n=19 articles were included in this systematic review and meta-analysis. Incidence of VTE (95% CI), PE (95% CI) and DVT (95% CI) was 23 (10-36) %, 12 (6-17) % and 15 (8-23) %. We have found a high but incidence of thromboembolic events in COVID-19 patients. Further well-designed studies are required in this area to identify true incidence and risk factors of it. O_LSTKey MessagesC_LSTO_LIThis meta-analysis of observational studies was designed to know worldwide prevalence of thromboembolic events in COVID-19 patients. C_LIO_LIData of more than 5000 patients from 19 observational studies were analyzed in this meta-analysis. C_LIO_LIIncidence of venous thromboembolism may be as high as 36% in these patients. C_LI

19.
Clin Trials ; 17(5): 491-500, 2020 10.
Article in English | MEDLINE | ID: covidwho-724657

ABSTRACT

BACKGROUND: Mortality from COVID-19 is high among hospitalized patients and effective therapeutics are lacking. Hypercoagulability, thrombosis and hyperinflammation occur in COVID-19 and may contribute to severe complications. Therapeutic anticoagulation may improve clinical outcomes through anti-thrombotic, anti-inflammatory and anti-viral mechanisms. Our primary objective is to evaluate whether therapeutic-dose anticoagulation with low-molecular-weight heparin or unfractionated heparin prevents mechanical ventilation and/or death in patients hospitalized with COVID-19 compared to usual care. METHODS: An international, open-label, adaptive randomized controlled trial. Using a Bayesian framework, the trial will declare results as soon as pre-specified posterior probabilities for superiority, futility, or harm are reached. The trial uses response-adaptive randomization to maximize the probability that patients will receive the more beneficial treatment approach, as treatment effect information accumulates within the trial. By leveraging a common data safety monitoring board and pooling data with a second similar international Bayesian adaptive trial (REMAP-COVID anticoagulation domain), treatment efficacy and safety will be evaluated as efficiently as possible. The primary outcome is an ordinal endpoint with three possible outcomes based on the worst status of each patient through day 30: no requirement for invasive mechanical ventilation, invasive mechanical ventilation or death. CONCLUSION: Using an adaptive trial design, the Anti-Thrombotic Therapy To Ameliorate Complications of COVID-19 trial will establish whether therapeutic anticoagulation can reduce mortality and/or avoid the need for mechanical ventilation in patients hospitalized with COVID-19. Leveraging existing networks to recruit sites will increase enrollment and mitigate enrollment risk in sites with declining COVID-19 cases.


Subject(s)
Antiviral Agents/therapeutic use , Betacoronavirus , Coronavirus Infections/drug therapy , Heparin/administration & dosage , Pneumonia, Viral/drug therapy , Thrombosis/prevention & control , Adolescent , Adult , Anticoagulants/administration & dosage , COVID-19 , Coronavirus Infections/complications , Coronavirus Infections/epidemiology , Dose-Response Relationship, Drug , Female , Humans , Male , Pandemics , Pneumonia, Viral/complications , Pneumonia, Viral/epidemiology , SARS-CoV-2 , Thrombosis/etiology , Treatment Outcome , Young Adult
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