Changes to trial information |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Trial Information |
Trial description |
08/05/2020 |
edit |
Epigenetics had been used successfully in the treatment of Viruses such as HIV and HCMV. Folic acid is known to correct epigenetic methylation pathway (1).
Folic acid had been used to correct methylation defects through epigenetic pathway in prevention of Neural tube defects such as spina bifida an is recommended by the FDA to be given as 600 micro-gram in pregnant females which prove the safety of the medication. It is also used in prevention of precancerous colonic lesions such as Polyps in addition to other therapeutic uses(2).
COVID-19 damages the immune system and organs through epigenetics and
methylation pathway (3).
In this study we suggest the use of Folic Acid stabilizes the DNA of human beings through methylation of the chromatin reader sites of the histone through epigenetic route which is the main site of action of COVID-19.
Another study from Iran suggested the use of Folic acid in prevention and treatment of COVID-19 cases and proved that it decreases the intracellular transport of the virus through a trans-membrane protein called Furin (4).
This study aims at detection of role of folic acid in prevention and control of COVID-19.
Zeina Nehme, Sébastien Pasquereau and Georges Herbein: Control of viral infections by epigenetictargeted therapy. Nehme et al. Clinical Epigenetics (2019) 11:55 https://doi.org/10.1186/s13148-019-0654-9
2. Krista S. Crider, Thomas P. Yang, Robert J Berry, and Lynn B. Bailey: Folate and DNA Methylation: A Review of Molecular Mechanisms and the Evidence for Folate’s Role. Nehme et al. Clinical Epigenetics (2019) 11:55 https://doi.org/10.1186/s13148-019-0654-9
3. https://www.whatisepigenetics.com/a-look-into-the-epigenetics-of-a-coronavirus-infection/
4. Zahra Sheybani, Maryam Heydari Dokoohaki, Manica Negahdaripour, Mehdi Dehdashti, Hassan Zolghadr, Mohsen Moghadami, Seyed Masoom Masoompour, Amin Reza Zolghadr: The Role of Folic Acid in the Management of Respiratory Disease Caused by COVID-19. March 2020. doi.org/10.26434/chemrxiv.12034980.v1
|
Epigenetics had been used successfully in the treatment of Viruses such as HIV and HCMV. Folic acid is known to correct epigenetic methylation pathway (1). Folic acid had been used to correct methylation defects through epigenetic pathway in prevention of Neural tube defects such as spina bifida an is recommended by the FDA to be given as 600 micro-gram in pregnant females which prove the safety of the medication. It is also used in prevention of precancerous colonic lesions such as Polyps in addition to other therapeutic uses(2). COVID-19 damages the immune system and organs through epigenetics and methylation pathway (3).
In this study we suggest the use of Folic Acid stabilizes the DNA of human beings through methylation of the chromatin reader sites of the histone through epigenetic route which is the main site of action of COVID-19. Another study from Iran suggested the use of Folic acid in prevention and treatment of COVID-19 cases and proved that it decreases the intracellular transport of the virus through a trans-membrane protein called Furin (4).
This study aims at detection of role of folic acid in prevention and control of COVID-19.
1. Zeina Nehme, Sébastien Pasquereau and Georges Herbein: Control of viral infections by epigenetictargeted therapy. Nehme et al. Clinical Epigenetics (2019) 11:55 https://doi.org/10.1186/s13148-019-0654-9
2. Krista S. Crider, Thomas P. Yang, Robert J Berry, and Lynn B. Bailey: Folate and DNA Methylation: A Review of Molecular Mechanisms and the Evidence for Folate’s Role. Nehme et al. Clinical Epigenetics (2019) 11:55 https://doi.org/10.1186/s13148-019-0654-9
3. https://www.whatisepigenetics.com/a-look-into-the-epigenetics-of-a-coronavirus-infection/
4. Zahra Sheybani, Maryam Heydari Dokoohaki, Manica Negahdaripour, Mehdi Dehdashti, Hassan Zolghadr, Mohsen Moghadami, Seyed Masoom Masoompour, Amin Reza Zolghadr: The Role of Folic Acid in the Management of Respiratory Disease Ca |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Intervention |
Intervention List |
08/05/2020 |
edit |
Experimental Group, Folic acid oral tablet., 500-1000 micro gram per day as a single or divided doses., 4 weeks., 3 population:
1. Health care works at risk while caring for COVID-19 carriers and cases. This poulation include:
Control group: will receive the already established protocols for prevention.
Intervention group: will receive Folic Acid "oral supplements' as 500-1000 micro gram per day as a single or divided doses.
2. Asymptomatic carriers with positive PCR.This poulation include:
Control group: will receive the already established protocols for treatment.
Intervention group: will receive Folic Acid "oral supplements' as 500-1000 micro gram per day as a single or divided doses.
3. Non-critical symptomatic COVID-!9 cases diagnosed by PCR. This poulation include:
Control group: will receive the already established protocols for treatment.
Intervention group: will receive Folic Acid "oral supplements' as 500-1000 micro gram per day as a single or divided doses.
, 30, |
Experimental Group, Folic acid oral tablet., 500-1000 micro gram per day as a single or divided doses., 4 weeks., 3 population:
1. Health care works at risk while caring for COVID-19 carriers and cases. This poulation include:
Control group: will receive the already established protocols for prevention.
Intervention group: will receive Folic Acid "oral supplements' as 500-1000 micro gram per day as a single or divided doses.
2. Asymptomatic carriers with positive PCR.This poulation include:
Control group: will receive the already established protocols for treatment.
Intervention group: will receive Folic Acid "oral supplements' as 500-1000 micro gram per day as a single or divided doses.
3. Non-critical symptomatic COVID-!9 cases diagnosed by PCR. This poulation include:
Control group: will receive the already established protocols for treatment.
Intervention group: will receive Folic Acid "oral supplements' as 500-1000 micro gram per day as a single or divided doses.
, 30, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Study Design |
Intervention assignment |
08/05/2020 |
To save time. |
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously |
Parallel: different groups receive different interventions at same time during study |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Sponsors |
Sponsors List |
08/05/2020 |
adding the postal Code. |
Faculty of Medicine Cairo university, Manail street., Cairo, , Egypt, Primary Sponsor, University, |
Faculty of Medicine Cairo university, Manail street., Cairo, 35855, Egypt, Primary Sponsor, University, |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
08/05/2020 |
to add the complete address and the PO code. |
Nadia Hafez Ouda and Hala Salah Eldin., Manial street, Cairo, , Egypt |
Nadia Hafez Ouda and Hala Salaf Eldin., Department of Microbiology. Faculty of Medicine. Cairo University, Almanial street 1, Cairo, 35855, Egypt |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Collaborators |
Collaborators List |
08/05/2020 |
Registering each co-author separately. |
Nadia Hafez Ouda and Hala Salah Eldin., Manial street, Cairo, , Egypt |
Nadia Hafez Ouda , Department of Microbiology. Faculty of Medicine. Cairo University, Almanial street 1, Cairo, 35855, Egypt |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Plan to share IPD |
08/05/2020 |
As requested by the PACTR registry administration. |
Undecided |
Yes |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD description |
08/05/2020 |
As requested by the PACTR registry administration. |
|
All the participants data collected during the trial will be available after deidentification. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD-Sharing time frame |
08/05/2020 |
As requested by the PACTR registry administration. |
|
After publication. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Key access criteria |
08/05/2020 |
As requested by the PACTR registry administration. |
|
Open access, raw data and data analysis, Through the main investigator, the Faculty of Medicine board will be a third party in this IPD according to qualifications and quality of the request. |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
IPD URL |
08/05/2020 |
As requested by the PACTR registry administration. |
|
https://medicine.cu.edu.eg/index.php/en/departments/36-microbiology6 |
Section Name
|
Field Name
|
Date
|
Reason
|
Old Value
|
Updated Value
|
Reporting |
Study protocol document |
08/05/2020 |
As requested by the PACTR registry administration. |
|
Study Protocol, Informed Consent Form, Clinical Study Report, Analytic Code |