Hantavirus Pulmonary SyndromeNCT00001123
A Collaborative Double-Blind Placebo-Controlled Trial of Intravenous Ribavirin As a Treatment for Presumed Hantavirus Pulmonary Syndrome
A study testing Ribavirin in people with Hantavirus Pulmonary Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
The purpose is to test the safety and effectiveness of intravenous ribavirin therapy in persons with suspected and subsequently proven hantavirus infection. The hantavirus is spread through the air into the lungs when dry rodent feces are moved or disturbed. It is characterized by fever and bleeding. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Hantavirus Pulmonary Syndrome
- What is being tested?
- Ribavirin
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento Nov 2005
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- You may be eligible for this study if you:
- Are 12 years of age or older.
- Are not pregnant.
- Agree to practice sexual abstinence or use accepted barrier methods of birth control/contraception.
- Are not breast-feeding.
- Have a positive blood test for hantavirus.
- Have symptoms suggestive of hantavirus illness.
Who cannot join
- You will not be eligible for this study if you:
- Have severe low blood count (anemia).
- Have a diagnosis of other respiratory viruses (influenza, RSV, etc.).
- Have group A Streptococcus with symptoms of streptococcal pharyngitis, a positive culture from a normally sterile site, or symptoms of bacterial pneumonia.
- Are HIV positive.
- Have cancer.
Show all 11Show fewer
- Have had any period of irregular heartbeat.
- Have had chemotherapy or other drugs that suppress the immune system within 30 days.
- Have taken by mouth or injection any antiviral drug (other than acyclovir, famciclovir, amantadine or rimantadine.)
- Have taken by mouth or injection corticosteroids equivalent to approximately 0.5 mg/kg prednisone.
- Have taken any experimental drug within 30 days prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
NIAID/DMID/CASG Central Unit
Birmingham, Alabama, 35294
About this study
The purpose is to test the safety and effectiveness of intravenous ribavirin therapy in persons with suspected and subsequently proven hantavirus infection. The hantavirus is spread through the air into the lungs when dry rodent feces are moved or disturbed. It is characterized by fever and bleeding.
Read the detailed description
Patients are randomized to receive either ribavirin or a placebo for 7 days. At the completion of therapy, patients will be seen on follow-up visits on days 14, 28, and 84.
- Conditions
- Hantavirus Pulmonary Syndrome
- Being tested
- Ribavirin
- Medical subject headings
- Hantavirus Pulmonary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RibavirinDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2001 (estimated)
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hantavirus Pulmonary SyndromeStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Masking
- Double blind
- Enrolment
- 130 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001123
- Sponsor's protocol ID
- 95-066
- Status last verified
- Nov 2005
- First submitted
- 17 Jan 2000
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Collaborative Double-Blind Placebo-Controlled Trial of Intravenous Ribavirin As a Treatment for Presumed Hantavirus Pulmonary Syndrome
- ClinicalTrials.gov ID
- NCT00001123
- Acronym / sponsor ID
- 95-066
- Conditions
- Hantavirus Pulmonary Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study completion
- Nov 2005
- First posted
- 31 Aug 2001 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose is to test the safety and effectiveness of intravenous ribavirin therapy in persons with suspected and subsequently proven hantavirus infection. The hantavirus is spread through the air into the lungs when dry rodent feces are moved or disturbed. It is characterized by fever and bleeding.
Detailed description
Patients are randomized to receive either ribavirin or a placebo for 7 days. At the completion of therapy, patients will be seen on follow-up visits on days 14, 28, and 84.
Study design
- Primary purpose
- Treatment
- Masking
- Double blind
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Are 12 years of age or older.
- Are not pregnant.
- Agree to practice sexual abstinence or use accepted barrier methods of birth control/contraception.
- Are not breast-feeding.
- Have a positive blood test for hantavirus.
Key exclusion criteria (11 listed)
- Have severe low blood count (anemia).
- Have a diagnosis of other respiratory viruses (influenza, RSV, etc.).
- Have group A Streptococcus with symptoms of streptococcal pharyngitis, a positive culture from a normally sterile site, or symptoms of bacterial pneumonia.
- Are HIV positive.
- Have cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ribavirin | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ribavirin in people with Hantavirus Pulmonary Syndrome, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2010; AzTrials last refreshed its copy on 7 Nov 2026.