Graphene Photothermal Adjuvant Therapy for Mild Corona Virus Disease 2019: A Prospective Randomized Controlled Trial

NCT ID: NCT05651815

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

270 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-22

Study Completion Date

2023-06-30

Brief Summary

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This is a future-proof and randomized controlled clinical study on the clinical efficacy of graphene photothermal adjuvant therapy in Corona Virus Disease 2019(COVID-19) patients with mild symptoms. The objective is to examine the effect of graphene photothermal adjuvant therapy on the time line for such Corona Virus Disease 2019 patients to achieve a negative severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleic acid test result, and their duration of disease. Patients who meet study criteria will be randomized into the Grapheme adjuvant therapy combined with conventional therapy group (treatment group) and the conventional therapy only group (control group). Contrasted to the control groups, the treatment groups will undergo 30-min of graphene adjuvant therapy every day for 7 d.

Detailed Description

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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.

Conditions

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COVID-19

Keywords

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Corona Virus Disease 2019 Randomized Control Trial Adjuvant Therapy Graphene Photothermal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Graphene spectrum light wave therapy room

Intervention Type DEVICE

Undergo 30-min of graphene adjuvant therapy every day for 7 d.

Conventional therapy group (control group)

Conventional therapy group (control group):Patients will only receive the conventional treatment for COVID-19.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Graphene spectrum light wave therapy room

Undergo 30-min of graphene adjuvant therapy every day for 7 d.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Meet the diagnostic criteria for mild COVID-19.
* Patients aged 18-60 years (inclusive).
* No later than 48 h after testing positive and the onset of clinical symptoms
* Sign informed consent form.

Exclusion Criteria

* Severe or critically patients with COVID-19.
* Resting heart rate over 120 beats per minute.
* Coronary heart disease patients with acute cardiac insufficiency.
* Acute exacerbation of chronic obstructive pulmonary disease(COPD).
* Uncontrolled hypertension \[resting systolic blood pressure(SBP) more than 180 mmHg and diastolic blood pressure(DBP) more than 90 mmHg\]; uncontrolled diabetes(Random Plasma Glucose, RPG\>16.7mmol/L, HbA1C\>7.0%)
* Patients with severe cardiovascular, hepatic, renal and hematopoietic diseases.
* Pregnant or menstruating woman.
* Known or suspected history of active tuberculosis or extrapulmonary tuberculosis, patients with brucellosis, pneumonia-related illness from other causes
* COVID-19 patients for the second or more times
* Those who cannot cooperate due to various reasons
* Body temperature: more than 38℃.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hohhot First Hospital

UNKNOWN

Sponsor Role collaborator

Southeast University, China

OTHER

Sponsor Role lead

Responsible Party

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Songqiao Liu

Zhongda Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Songqiao Liu, PhD.

Role: STUDY_CHAIR

Southeast University

Locations

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Hohhot First Hospital

Hohhot, Inner Mongolia, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Songqiao Liu, PhD.

Role: CONTACT

Phone: 086-02583262550

Email: [email protected]

Junjing Zhang

Role: CONTACT

Phone: 086-04175281618

Email: [email protected]

Facility Contacts

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Junjing Zhang

Role: primary

Other Identifiers

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IRB2022075

Identifier Type: -

Identifier Source: org_study_id