Graphene Photothermal Adjuvant Therapy for Mild Corona Virus Disease 2019: A Prospective Randomized Controlled Trial
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|ClinicalTrials.gov Identifier: NCT05651815|
Recruitment Status : Recruiting
First Posted : December 15, 2022
Last Update Posted : December 15, 2022
|Condition or disease||Intervention/treatment||Phase|
|COVID-19||Device: Graphene spectrum light wave therapy room||Not Applicable|
Following enrollment, patients will be randomized into treatment or control groups. All groups will receive the same conventional therapy.
In addition, treatment groups will undergo Graphene adjuvant therapy 30 minutes per day for 7 d.
Upon completion of the treatment protocol, specific study endpoints will be compared between the treatment and control groups.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||270 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Graphene Photothermal Adjuvant Therapy for Mild Corona Virus Disease 2019: A Prospective Randomized Controlled Trial|
|Actual Study Start Date :||November 22, 2022|
|Estimated Primary Completion Date :||December 31, 2022|
|Estimated Study Completion Date :||June 30, 2023|
Experimental: Graphene adjuvant therapy combined with conventional therapy group (treatment group)
Graphene adjuvant therapy combined with conventional therapy group (treatment group)：Contrasted to the control groups, the treatment groups will undergo 30-min of graphene adjuvant therapy every day for 7 d.
Device: Graphene spectrum light wave therapy room
Undergo 30-min of graphene adjuvant therapy every day for 7 d.
No Intervention: Conventional therapy group (control group)
Conventional therapy group (control group)：Patients will only receive the conventional treatment for COVID-19.
- The time from positive at baseline to negative SARS-CoV-2 nucleic acid test [ Time Frame: through study completion, an average of 10 days ]The time for grouped patients to receive a negative SARS-CoV-2 nucleic acid test result, including both ORF gene Ct value≥35 and N gene Ct value≥35.
- Hospital stay [ Time Frame: through study completion, an average of 15 days ]Time to hospitalization for COVID-19
- Negative test rate within 7 days [ Time Frame: 7 days ]the rate of negative test of patients
- Mild to moderate rate within 14 days [ Time Frame: 14 days ]Mild to moderate rate within 14 days
- Lymphocytes variation [ Time Frame: through study completion, an average of 15 days ]Lymphocytes count
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05651815
|Contact: Songqiao Liu, PhD.||email@example.com|
|Contact: Junjing Zhangfirstname.lastname@example.org|
|China, Inner Mongolia|
|Hohhot First Hospital||Recruiting|
|Hohhot, Inner Mongolia, China, 010031|
|Contact: Junjing Zhang 086-04175281618 email@example.com|
|Study Chair:||Songqiao Liu, PhD.||Southeast University|