Clinical trial NCT05271461: COVID-19 Hyper Coagulability Care by LLLT
Official title: Effect of Low Level Laser Therapy on Hyper Coagulability in Patients With Covid-19
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COVID-19 Pneumonia
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-03-09
Enrollment: 60
Sex: ALL
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups of 30 patients, 1st circulatory exercise, 2nd LLLT and circulatory exercises.
Primary purpose: PREVENTION

Brief summary: COVID-19 clotting Safety

Detailed description: Covid-19 patients have liability for hyper coagulability, low level laser Therapy improve circulation and decrease liability for hyper coagulability accompanied with circulatory exercises .

Eligibility criteria: Inclusion Criteria:

* BMI from 18.5 to 29.9 kg/m2
* Moderate elevated percentage of coagulative factors for COVID-19 Diagnosis:
* Nasopharyngeal swab
* Sepsis induced coagulopathy score\>4
* D_dimer≥0,5mg/L
* Fibrinogen\>2,5gm/L
* C_reactive protein≥10mg/L
* Lymphocyte count\<1,500mm3
* Platelet count\<150,000mm3
* Prothrombin time increase\>3sec
* Activated partial thromboplastin time increase\>5sec
* Same level of physical activity
* Patients can swallow tablets
* CT scan screening method for COVID-19 Diagnosis
* Physical examination

Exclusion Criteria:

* hyper tension
* Cognitive impairment e.g (delirium)
* Diabetes mellitus both types dependant or non
* Disabled musculoskeletal Disorders e.g hemi paresis
* Coronary artery diseases and heart failure
* DVT
* Stroke, bone disease, renal failure, pulmonary embolism
* Vitamins deficiency
* 6 months post large surgeries
* Alcohol intake and smokers
* Thyroid diseases

Primary outcomes:
measure: Circulatory group laboratory investigation.
timeFrame: Monthly (an average of two months)
measure: Circulatory group: CBC analysis.
timeFrame: Daily (an average of two months)
measure: Circulatory group (PT, PTT).
timeFrame: Bi weekly (an average of two months)
measure: Circulatory group physical examination.
timeFrame: Every two days (an average of two months)
measure: Circulatory group. BMI.
timeFrame: Day one
measure: Especially Lab investigation.
timeFrame: Baseline
Secondary outcomes:
measure: LLLT group laboratory investigation.
timeFrame: Monthly (an average of two months)
measure: LLLT group CBC analysis.
timeFrame: Daily (an average of two months)
measure: LLLT group. {PTT, PT}.
timeFrame: Bi weekly (an average of two months)
measure: LLLT group physical examination.
timeFrame: Every two days (an average of two months)
measure: LLLT group. BMI.
timeFrame: Day one
measure: Specifically Lab investigation.
timeFrame: Baseline
Other outcomes:
Locations:
city: Dokki
country: Egypt
facility: Physical therapy faculty
state: Giza
Study officials:
affiliation: Physical therapy faculty CairoU.
name: Enas Dr Ahmed, BSC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agaiby AD, Ghali LR, Wilson R, Dyson M. Laser modulation of angiogenic factor production by T-lymphocytes. Lasers Surg Med. 2000;26(4):357-63. doi: 10.1002/(sici)1096-9101(2000)26:43.0.co;2-o.
citation: Emami A, Javanmardi F, Pirbonyeh N, Akbari A. Prevalence of Underlying Diseases in Hospitalized Patients with COVID-19: a Systematic Review and Meta-Analysis. Arch Acad Emerg Med. 2020 Mar 24;8(1):e35. eCollection 2020.
citation: ConnorsJ.M.,LevyJ.H(2020).Thromboinflammation and the hyper coagulability of COVID-19.JThromb Haemost https://doi.org/10.1111/jth.14849.