Plain English Summary
Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
After a temporary slowdown in summer 2020 infection numbers and death rates have been increasing again in recent months leading to various restrictions of social and economic life in many countries. The latest developments of new vaccinations seem to be promising; however, large-scale production and worldwide distribution logistics take time while questions such as longevity of immune protection, long-term side-effects etc are remaining unclear at this point. Furthermore, vaccination is a preventive approach and not a treatment for acutely infected patients. Treatments are still needed to help people with COVID-19 infection. The aim of this study is to find out whether photodynamic therapy (PDT) with riboflavin and a specially designed light treatment kit would be able to fill this gap by helping people in the early stages of infection. This may lead to relief for hospitals and intensive care stations.
Who can participate?
Acutely infected COVID-19 patients aged 10-90 from Gandhi hospital in Tehran
What does the study involve?
Participants are randomly allocated to receive either photodynamic therapy plus daily testing for 5 days or to receive conventional care plus testing. Viral load is measured at the start of the study and after 24, 48, 72, 96, 120 and 168 hours.
What are the possible benefits and risks of participating?
Possible benefits are lowering the viral load and improving the symptoms of Covid-19 patients. There are no significant risks or side effects to be expected according to safety measurements that have been done before.
Where is the study run from?
Gandhi Hospital (Iran)
When is the study starting and how long is it expected to run for?
September 2020 to February 2021
Who is funding the study?
Weber Medical (Germany)
Who is the main contact?
Dr. med. Michael Weber
robert.weber@webermedical.com
Study website
Contact information
Type
Scientific
Contact name
Dr Michael Weber
ORCID ID
Contact details
Sohnreystrasse 4
Lauenfoerde
37697
Germany
+49 (0)5273367780
robert.weber@webermedical.com
Additional identifiers
EudraCT/CTIS number
Nil known
IRAS number
ClinicalTrials.gov number
Nil known
Protocol/serial number
Covid2021001
Study information
Scientific title
Successful reduction of SARS-CoV-2 viral load by photodynamic therapy verified by quantitative PCR – a novel approach in treating patients in early infection stages
Acronym
Study hypothesis
The objective of this study is to evaluate if Photodynamic Therapy (PDT) with riboflavin and a specially designed light treatment kit would be able to help people in the early stages of infection by reducing viral load and clinical symptoms.
Ethics approval(s)
No ethical approval required because of the emergency COVID-19 situation in Tehran/Iran in November 2020
Study design
Interventional non-randomized study
Primary study design
Interventional
Secondary study design
Non randomised study
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
No participant information sheet available
Condition
COVID-19 (SARS-CoV-2 infection)
Intervention
Patients are assigned in the sequence of hospital admission to two groups with 70 patients in the experiment (verum) group receiving daily Photodynamic Therapy and daily testing for 5 days and a control group receiving conventional care plus testing for 5 days. All patients in both groups had positive COVID-19 test results at the beginning of the study. They were in an early infection stage with mild symptoms like fever, dry cough, headache, hard breathing, fatigue etc. Quantitative PCR (QPCR) tests with Ct-viral load are performed on day 1, 2, 3, 4, 5 and 7 in the experiment group and on day 1, 3, 5 and 7 in the control group.
Intervention type
Mixed
Primary outcome measure
Viral load measured using the QPCR test (Ct value) at baseline, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours and 168 hours
Secondary outcome measures
Clinical symptoms measured using the visual analogue score (VAS) at baseline, 24 hours, 48 hours, 72 hours, 96 hours, 120 hours and 168 hours
Overall study start date
02/09/2020
Overall study end date
28/02/2021
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Men and women
2. Aged 10-90 years
3. Early stages of COVID-19 (SARS-CoV-2 infection)
Participant type(s)
Patient
Age group
Mixed
Sex
Both
Target number of participants
140
Total final enrolment
140
Participant exclusion criteria
1. Late infection stages
2. Pregnant women
3. Children aged under 10 years
Recruitment start date
01/11/2020
Recruitment end date
15/02/2021
Locations
Countries of recruitment
Iran
Study participating centre
Gandhi Hospital
Gandhi St, No. 130
Tehran
1000
Iran
Sponsor information
Organisation
International Society for Medical Laser Applications
Sponsor details
Loensstr. 10
Lauenfoerde
37697
Germany
+49 (0)52733677818
info@isla-laser.org
Sponsor type
Research organisation
Website
Funders
Funder type
Industry
Funder name
Weber Medical
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Planned publication in a high-impact peer-reviewed journal
Intention to publish date
01/05/2021
Individual participant data (IPD) sharing plan
The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication.
IPD sharing plan summary
Other
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|