DAS181 in Patients With Parainfluenza

NCT01441024 | Withdrawn Phase 2

• 2 other identifiers: 11020511-I-0205
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

Background: \- Parainfluenza is a virus that can cause infections in people. Most people infected with this virus have mild symptoms including fever, cough, red eyes, or runny nose (a common cold). Some people, especially those with a weakened immune system, get very sick from this virus. They may have difficulty breathing or develop lung infections. Currently, there are no specific treatments for parainfluenza. However, a drug called DAS181 may make the virus go away faster. Researchers are interested in testing DAS181 to see if it is safe and effective against parainfluenza. Objectives: \- To test the safety and effectiveness of DAS181 as a treatment for parainfluenza. Eligibility: \- Individuals at least 18 years of age who have the parainfluenza virus and have developed symptoms within the past 10 days. Design:

• Participants will be screened with a physical exam, medical history, and questions about symptoms and activity levels. Participants will also have a lung function test and provide blood and nasal fluid samples.
• DAS181 is an inhaled medication, and everyone will receive a study medication inhaler. Participants will receive either DAS181 or a placebo through the inhaler. They will take it once every day for 5 days.
• Participants will have monitoring visits on days 2, 4, 7, 10, 14, and 28 to provide blood and nasal fluid samples and have a lung function test.
• Participants who still have the virus in their system on Day 28 will return to the clinic on Day 42 for more tests. Participants who still have the virus in their system on Day 42 will return to the clinic on Day 56 for more tests.
• Participants will have followup visits 6 months and 1 year after the start of the study.

Conditions

Parainfluenza Infection

Keywords

Immunocompromised; Respiratory Tract Disease; Viral Shedding; Fever; Pharmacokinetics; Parainfluenza Infection; Flu

Outcome Measures

Primary Outcomes (1)

• Number patients with at least 1 grade 3/4/SAE that are possibly, probably, or definitely related to the study product by Study Day 28.

  study day 28

Secondary Outcomes (2)

• Virologic Endpoints: Viral shedding by qualitative PCR or culture.

  1 year

• Clinical Endpoints: Clinical symptoms, Fever, Radiographic evidence of lower tract disease by CT (if obtained clinically), Death, Hospitalization, Use of supplemental oxygen.

  1 year

Study Arms (2)

1

EXPERIMENTAL

DAS181

Drug: DAS181

2

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

DAS181 DRUG

20 mg per day of DAS181-FO3 for 5 days

1

Placebo OTHER

20 mg per day of Lactose for 5 days

2

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age greater than or equal to 18 years
• Positive culture, DFA, PCR or other clinical assay for parainfluenza
• Symptomatic upper or lower respiratory tract disease (e.g., pharyngitis, cough, tracheobronchitis, bronchiolitis, pneumonia). Fever alone is not sufficient.
• Onset of illness within the last 10 days
• Females who are able to become pregnant (i.e., are not postmenopausal, have not undergone surgical sterilization, and are sexually active with men) must agree to use at least 2 effective forms of contraception from the date of informed consent through Study Day 28 of the study. At least 1 of the methods of contraception should be a barrier method
• Willingness to have samples stored

You may not qualify if:

• Known hypersensitivity to DAS181 or any of its components
• Women who are pregnant (positive serum or urine pregnancy test), who are attempting to become pregnant, or who are breast-feeding
• Mechanical ventilation, acute respiratory distress, or otherwise unable to tolerate the drug delivery device (Cyclohaler)
• Allergy or history of allergy to milk or lactose
• Previous or current history of asthma or chronic obstructive pulmonary disease (COPD) requiring daily medication
• Any significant findings in the patient s medical history or physical examination that, in the opinion of the investigator, would affect patient safety or compliance with the dosing schedule

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Related Publications (3)

• Henrickson KJ. Parainfluenza viruses. Clin Microbiol Rev. 2003 Apr;16(2):242-64. doi: 10.1128/CMR.16.2.242-264.2003.

  PMID: 12692097 BACKGROUND

• Weintrub PS, Sullender WM, Lombard C, Link MP, Arvin A. Giant cell pneumonia caused by parainfluenza type 3 in a patient with acute myelomonocytic leukemia. Arch Pathol Lab Med. 1987 Jun;111(6):569-70.

  PMID: 3034189 BACKGROUND

• Apalsch AM, Green M, Ledesma-Medina J, Nour B, Wald ER. Parainfluenza and influenza virus infections in pediatric organ transplant recipients. Clin Infect Dis. 1995 Feb;20(2):394-9. doi: 10.1093/clinids/20.2.394.

  PMID: 7742447 BACKGROUND

MeSH Terms

Conditions

Paramyxoviridae Infections; Respiratory Tract Diseases; Fever; Influenza, Human

Interventions

oplunofusp

Condition Hierarchy (Ancestors)

Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections; Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiratory Tract Infections; Orthomyxoviridae Infections

Study Officials

• Richard T Davey, M.D.

  National Institute of Allergy and Infectious Diseases (NIAID)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2011
• First Posted: September 27, 2011
• Study Start: July 14, 2011
• Primary Completion: February 27, 2014
• Study Completion: June 30, 2014
• Last Updated: December 17, 2019

Record last verified: 2014-02-27