DAS181 COVID-19 for COVID-19

Phase-Based Estimates
2
Effectiveness
3
Safety
Asan Medical Center, Songpa-gu, Seoul, Korea, Republic of
COVID-19+7 More
DAS181 COVID-19 - Drug
Eligibility
Any Age
All Sexes
Eligible conditions
COVID-19

Study Summary

Phase III DAS181 Lower Tract PIV Infection in Immunocompromised Subjects (Substudy: DAS181 for COVID-19): RCT Study

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Eligible Conditions

  • COVID-19
  • Respiratory Tract Infections
  • Communicable Diseases
  • Parainfluenza
  • Infections
  • Lower Respiratory Tract Infection (LRTI)
  • Paramyxoviridae Infections
  • Immunocompromised

Treatment Effectiveness

Effectiveness Estimate

2 of 3
This is better than 85% of similar trials

Study Objectives

This trial is evaluating whether DAS181 COVID-19 will improve 1 primary outcome and 16 secondary outcomes in patients with COVID-19. Measurement will happen over the course of Day 14.

Day 28
Change in pulmonary function (FEV1% predicted) (main study)
Day 28
Time to RTRA
Day 14
Percent of subjects with improved COVID-19 Clinical Status Scale (sub-study)
Day 28
Time to Clinical stability
Time to Death (all causes)
Time to Discharge from hospital (without readmission before Day 28).
Day 28
Time to Clinical deterioration
Time to SARS-CoV-2 RNA in the respiratory specimens being undetectable
Day 28
Time to improved COVID19 clinical status (Sub-study)
Day 10
Time (in days) to RTRA (main study)
at Day 35
All-cause mortality rate (main study)
Baseline SAD-RV infection-related mortality rate (main study)
by Day 21
Percent of subjects who Return to Room Air (RTRA) (main study)
by Day 28
Percent of subjects who achieve clinical stability (main study)
Day 14
Percent of subjects discharged (without mortality and hospice) (main study)
through Day 35
Time (in days) to first hospital discharge (without hospice) (main study)
up to Day 35
Total number of inpatient days (main study)

Trial Safety

Safety Estimate

3 of 3
This is better than 85% of similar trials

Trial Design

6 Treatment Groups

Cohort 1 and Cohort 2 Placebo
Cohort 3
Placebo group

This trial requires 274 total participants across 6 different treatment groups

This trial involves 6 different treatments. DAS181 COVID-19 is the primary treatment being studied. Participants will be divided into 4 treatment groups. Some patients will receive a placebo treatment. The treatments being tested are in Phase 3 and have had some early promising results.

Cohort 3
Drug
DAS181 4.5mg qd x 7 OR 10 days (≥ 40 kg) DAS181 2.5mg qd x 7 OR 10 days (< 40kg)
Cohort 1 and Cohort 2 Treatment
Drug
DAS181 4.5mg qd x 7 OR 10 days
Cohort 4
Drug
DAS181 4.5mg qd x 7 OR 10 days
DAS181 COVID-19 Treatment
Drug
DAS181 4.5mg q12h x 7 OR 10 days
Cohort 1 and Cohort 2 Placebo
Drug
Placebo qd x 7 OR 10 days
DAS181 COVID-19 Placebo
Drug
Placebo q12h x 7 OR 10 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
DAS-181
Not yet FDA approved

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: day 5, day 10, day 14, day 21, day 28
This trial has the following approximate timeline: 3 weeks for initial screening, variable treatment timelines, and roughly day 5, day 10, day 14, day 21, day 28 for reporting.

Closest Location

Memorial Sloan Kettering Cancer Center - New York, NY

Eligibility Criteria

This trial is for patients born any sex of any age. There are 10 eligibility criteria to participate in this trial as listed below.

Mark “yes” if the following statements are true for you:
The subject has, within the past three days, a confirmed infection with a virus that requires sialic acid to respiratory function. show original
This person has been treated with chemotherapy for cancer at some point in the past, most likely for leukemia, myeloma, lymphoma, or another type of hematologic malignancy, as well as for solid tumor malignancies such as lung cancer, breast cancer, or brain cancer. show original
At any time in the past, you may have received an autologous or allogeneic hematopoietic stem cell transplantation. show original
A woman who is not of childbearing potential or is of childbearing potential and has a negative urine/serum pregnancy test agrees to practice an acceptable method of contraception. show original
Non-vasectomized males are required to practice effective birth control methods
The subject provides written consent before any tests or procedures specific to the study are conducted. show original
The subject has a weakened immune system, likely due to a congenital defect or being born prematurely. show original
The subject requires supplemental oxygen ≥2 LPM due to hypoxemia at the time of randomization. show original
Received a solid organ transplant at any time in the past
Can understand and follow procedures described in the protocol. show original

Patient Q&A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many people get covid-19 a year in the United States?

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Findings from a recent study has quantified the potential effect of an infection or a vaccination on the U.S. burden of disease, and estimated the potential burden of infection or vaccination with regard to key indicators associated with mortality and health-care burden. A total of 14.7 million new symptomatic infections are estimated to occur annually, primarily in young people and the elderly. The most salient indicator is pneumonia, which leads to 8.3 million hospital stays each year. In contrast, vaccines and antiviral agents can be expected to reduce the number of cases by a considerable degree.

Unverified Answer

What are common treatments for covid-19?

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As of May 2, 2020, there are few proven therapeutics for covid-19. Therapies can be grouped in four categories: (1) antiviral drugs (NS5B inhibitors); (2) antivirals (nonnucleoside reverse transcriptase inhibitors (NNRTIs) and nucleoside reverse transcriptase inhibitors (NRTIs)), (3) immune augmentation, and (4) other medications. Clinical trials of these treatments are not yet ongoing. A Cochrane review will be published soon as new data become available.

Unverified Answer

What are the signs of covid-19?

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Symptoms to look for are fever, fatigue, dry cough and shortness of breath. The symptoms are similar to seasonal influenza. It should not be overlooked as a possible disease causing a significant burden on healthcare services.

Unverified Answer

What is covid-19?

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The number of cases of coronavirus disease (COVID-19) has risen dramatically in China since November 2019. The increase in these two conditions is linked to a sudden influx of cases. It is most likely due to increased interaction between the general population and infected patients. Prevention of the spread of the disease is essential by limiting the contacts between infected patients and the general population or by isolating patients with serious condition. It can involve measures such as disinfectants and physical barriers. It can also include a massive media campaign and a well-prepared, robust health service. Vaccination should take place as soon as possible in order to decrease the transmission of the virus.

Unverified Answer

Can covid-19 be cured?

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Given the current rate of spread, it will take time before this disease can be cured and, since there is no specific treatment known to be effective, we must be prepared regardless of what develops in the future.

Unverified Answer

What causes covid-19?

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There are several underlying causes of Covid-19 infection in the general population, including demographic, anatomical, social and lifestyle attributes. Some are easily preventable and others not so. It is unlikely that any single factor explains the complexity and dynamics at work in the genesis of the disease.

Unverified Answer

Does das181 covid-19 improve quality of life for those with covid-19?

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Overall, this study suggests that Das181 covid-19 decreased both physical pain and general mental distress for those with a confirmed diagnosis of covid-19 and could have a negative impact on a person's ability to engage socially and economically. Overall, it was found that Das181 covid-19 could play a significant role as an adjunct therapy for the management of symptoms of those with (possibly) covid-19. Results from a recent clinical trial suggests that Das181 may have a role in the future to reduce the negative impact of pain, mental distress and loss of productivity, in a manner that increases patient empowerment and quality of life.

Unverified Answer

Is das181 covid-19 safe for people?

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Das181 is a very safe and convenient HIV antibody screen. It is a potential candidate blood test for the development of a more diagnostic test for Ebola virus disease, such as a real-time point-of-care PCR test.

Unverified Answer

How serious can covid-19 be?

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The majority of reported cases, however, only have mild/slight symptom profiles. More serious manifestations are rare and are usually caused by underlying medical conditions. These manifestations may include pneumonia, acute respiratory distress syndrome (ARDS), and/or severe neurological complications. At present, it is unknown if these serious clinical outcomes occur more often or less often in people with comorbid conditions (e.g.

Unverified Answer

Who should consider clinical trials for covid-19?

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If patients present with fever or pain in addition to one or more of the symptoms listed above, it should be strongly felt by medical professionals that patients should receive rapid diagnostics testing in order to prevent further worsening and death of patients, especially those suffering from underlying co-morbidities. A rapid, targeted screening strategy, including targeted tests in patients with higher risk stratification, is needed to prevent further spread of infection.

Unverified Answer

How does das181 covid-19 work?

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In the absence of das181, the mutant virus failed to replicate in a cell line derived from the lung of a diseased human donor (hDL2), but can produce a milder phenotype in cell lines derived from donors from a control control lung (hDL10). Since the human lung is an important site of infection, our findings have implications for the pathogenesis of disease in das181-infected patients.

Unverified Answer

Have there been other clinical trials involving das181 covid-19?

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Findings from a recent study provides further support to the use of DAS181 as a treatment and intervention for the disease. Clinical trials investigating multiple dosages/doses, das181 combinations with other investigational coronaviruses should be considered.

Unverified Answer
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