Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00215826
Other study ID # LDO-102
Secondary ID
Status Completed
Phase Phase 2
First received September 16, 2005
Last updated April 16, 2013
Start date November 2004
Est. completion date April 2006

Study information

Verified date April 2013
Source Hemispherx Biopharma
Contact n/a
Is FDA regulated No
Health authority Hong Kong: Department of HealthUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

This study will be an open-label, randomized, outpatient study in subjects potentially infected with the SARS-CoV (SARS-associated coronavirus) or normal volunteers using two dose levels of LDO interferon.

Subjects will be randomized to receive Alferon® LDO (natural interferon alfa-n3) in a buffer solution once each day for 10 consecutive days at doses equal to 650 IU or 1300 IU/day.

Pretherapy baseline evaluations will be performed prior to randomization.

Subjects will be randomly assigned to each dose level, and both dosage levels will be started concurrently. Drug will be dispensed for a ten day treatment period, during which time any clinical symptoms and adverse events will be evaluated. Laboratory samples (2.5 ml blood) for microarray analysis evaluations will be made twice during baseline and 12-14 hours following doses 1, 5, and 10 on study days 2, 6, and 11, respectively.

The conduct of this study will comply with International Conference on Harmonisation - Good Clinical Practice (ICH - GCP) and the 1996 or later version of the Declaration of Helsinki.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date April 2006
Est. primary completion date April 2006
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. 18-80 years of age.

2. Asymptomatic with close contact within the last 5 days with a person known to have possible SARS (SARS RUI-2 (SARS Report under investigation), RUI-3, RUI-4) or probable SARS or confirmed SARS using the Centers for Disease Control and Prevention (CDC) Supplement B: SARS Surveillance, Appendix B1: Revised Council of State and Territorial Epidemiologists (CSTE) SARS Surveillance Case Definition (Attachment II).

3. Oral temperature < 100.4°F (<38°C)

4. Subjects must be asymptomatic with regard to SARS related clinical symptoms including any signs of a respiratory illness.

5. Serum creatinine = 1.5 x ULN (upper limit of normal); serum bilirubin = 1.5 x ULN.

6. Total white blood cells (WBC) = 3000/mm3, platelet count = 100,000/mm3 and granulocytes = 1500 mm3.

7. Hemoglobin > 10.0 g/dl.

8. ALT (alanine aminotransferase) and AST (aspartate aminotransferase) < 4 times upper normal limit.

9. C-reactive protein serum level in normal range

10. Serum albumin > 2.0 g/dl.

11. Written informed consent.

12. Females must either be of non-child bearing potential, or utilize an effective form of contraception and have a negative pregnancy test prior to randomization.

Exclusion Criteria:

1. Pregnant or nursing women, or women not using an effective form of contraception.

2. Less than 18 years of age.

3. Active intravenous (IV) drug users.

4. Receipt of any immunosuppressive agent, chemotherapy, or systemic steroids within 45 days of study entry.

5. Receipt of any immunomodulator such as BCG (bacille Calmette Guerin) vaccine, isoprinosine, or similar experimental agents within 45 days of study entry.

6. Evidence of HIV or other viral infections including chronic hepatitis, or other active gastrointestinal, renal, respiratory, endocrine, hematologic, cardiovascular, neurological, or psychiatric disorder that would limit the subject's ability to complete the study period.

7. Unlikely or unable to comply with the requirements of the protocol.

8. Patients unwilling or unable to give informed consent.

9. Patients on any other concurrent experimental medication.

10. Patients using any form of interferon therapy during the 6 weeks prior to study entry.

11. Hospitalized subjects, or those with an active viral infection other than possible SARS, within 2 weeks of study entry.

12. Transfusion dependent subjects (subjects requiring > 1 unit of packed RBC [red blood cells] per month within the 3 months prior to study entry).

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Alferon LDO


Locations

Country Name City State
Hong Kong Princess Margaret Hospital Lai Chi Kok Kowloon

Sponsors (1)

Lead Sponsor Collaborator
Hemispherx Biopharma

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gene expression analysis Increased expression of genes known to be mediators of interferon response. Days 0, 2, 6, 11, 12, 15, 20 and 40 No
Secondary SARS CoV Antibody Development of clinical SARS-CoV symptomatology Days 0, 15, 20 and 40 Yes
Secondary SARS-CoV infection Hospitalization for SARS-CoV infection and Death Yes
See also
  Status Clinical Trial Phase
Completed NCT04542915 - COVID-19-Related Health and Practices Among Dental Hygienists
Completed NCT04515147 - A Dose-Confirmation Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults for COVID-19 Phase 2
Recruiting NCT04480333 - Safety, Tolerability and Pharmacokinetics of Inhaled Nanoparticle Formulation of Remdesivir (GS-5734) and NA-831 Phase 1
Completed NCT04402957 - LSALT Peptide vs. Placebo to Prevent ARDS and Acute Kidney Injury in Patients Infected With SARS-CoV-2 (COVID-19) Phase 2
Withdrawn NCT04838847 - A Study to Evaluate the Immunogenicity and Safety of the SARS-CoV-2 mRNA Vaccine CVnCoV in Elderly Adults Compared to Younger Adults for COVID-19 Phase 3
Not yet recruiting NCT04386070 - Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19 Phase 3
Withdrawn NCT00073086 - Evaluation and Treatment of Severe Acute Respiratory Syndrome (SARS) N/A
Active, not recruiting NCT04527432 - COVID-19 Health Professional Impact Study N/A
Completed NCT04366934 - Study of the Pathogenesis of Olfactory Disorders in COVID-19
Completed NCT04402060 - A Study of APL-9 in Adults With Mild to Moderate ARDS Due to COVID-19 Phase 1/Phase 2
Completed NCT04376684 - Investigating Otilimab in Patients With Severe Pulmonary COVID-19 Related Disease Phase 2
Completed NCT04395144 - COVid-19: Awake Proning and High-flow Nasal Cannula in respiratorY DistrEss N/A
Completed NCT04357730 - Fibrinolytic Therapy to Treat ARDS in the Setting of COVID-19 Infection Phase 2
Completed NCT04425213 - Obesity and Mortality of Critically Ill Patients With COVID-19
Completed NCT04425863 - Ivermectin, Aspirin, Dexamethasone and Enoxaparin as Treatment of Covid 19
Completed NCT06287554 - Effect of Early Implementation of Prone Positioning
Completed NCT04328129 - Household Transmission Investigation Study for COVID-19 in Tropical Regions N/A
Completed NCT04602351 - Communication in ICU During COVID-19
Completed NCT03225807 - Implementation of Lung Protective Ventilation in Patients With Acute Respiratory Failure
Recruiting NCT04381819 - Norwegian SARS-CoV-2 Study - Virological, Clinical and Immunological Characterisation of COVID-19