RE: ACTIV-2 clinical trial protocol1 Mar 2021 22:19
Helen - thank you for the document.
One extract I found interesting was in the appendix relating to Synairgen's good safety record as detailed below - also of significance it that trial participants will be in the program for almost 6 months.
HOW LONG WILL I BE IN THIS STUDY?
If you are assigned to SGN001 or placebo for SGN001, you will be in this study for 24
weeks.
WHAT ARE THE RISKS OF SNG001?
There is a risk of serious and/or life-threatening side effects when non-study medications
are taken with the study drugs. For your safety, you must tell the study doctor or nurse
about all medications you are taking before you start the study.
Another risk is that the study drug used in this study may have side effects, some of which
are listed below. Additionally, the study drug tested in the study may have unknown side
effects in persons with SARS-CoV-2 infection. In a research study, all of the risks or side
effects may not be known before you start the study. You need to tell your doctor or a
member of the study team immediately if you experience any side effects.
Please note that these lists do not include all the side effects seen with this study drug.
These lists include the more serious or common side effects with a known or possible
relationship to the study drug. If you have questions concerning the additional side effects,
please ask the medical staff at your site.
Risks Associated with Inhaled SNG001
There is limited safety data on inhaled SNG001 since it has not been given to a lot of
people. This study will be one of the first studies to give inhaled SNG001 to nonhospitalized
patients with COVID-19. A study of inhaled SNG001 in COVID-19 outpatients
was recently started in the UK. As of December 4, 2020, there have been no serious
unwanted effects reported by >300 healthy people and patients with asthma, as well as 100
COVID-19 patients, taking inhaled SNG001. Most effects after taking inhaled SNG001 or
placebo for SNG001 have been mild or moderate and have either all gone away or are
getting better.
Based on previous trials, administration of inhaled SNG001 may result in
β’ Fast heart rate
β’ Coughing
β’ Deposits of drug product on the top and back of mouth and throat
β’ Dry throat
β’ Hoarseness of voice
β’ Sneezing
β’ Tremors
β’ Headache
There is extensive experience from individuals who have received intravenous injections of
IFN-Γ-1, as this is has been approved for treatment of multiple sclerosis in the United
States since 1996. The most common side effects from intravenous injections of IFN-Γ-1
are mild and short-lived, including flu-like symptoms such as headache, fever, muscle
aches, and chills. Rare side effects that have been reported from intravenous injections of
IFN-Γ-1 include severe allergic reactions, low white blood cell counts, liver injury, kidney
injury, seizures, depression, and suicidal thoughts. EndQuote